BGS Beta-Gamma-Service GmbH & Co KG

FDA Device Registration & Listing · Bruchsal Baden-Wurttemberg, DE · Registration 3005562917

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005562917
FEI Number
3005562917
Entity Name
BGS Beta-Gamma-Service GmbH & Co KG
City/State/Country
Bruchsal Baden-Wurttemberg, DE
Establishment Address
John-Deere-Str. 3, Bruchsal Baden-Wurttemberg 76646, DE
Establishment Type(s)
Sterilize Medical Device for Another Party (Contract Sterilizer)
Owner / Operator
BGS Beta-Gamma-Service GmbH & Co KG (Owner Number: 10043097)
Owner / Operator Contact Address
Fritz-Kotz-Strasse 16, Wiehl, DE-NW 51674, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2018-12-07
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2018-12-07
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2025-12-15
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2025-12-15
MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown Class 3 N/A 2025-07-05
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2015-11-02
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2015-11-02
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2015-11-02
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2015-11-02
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2020-12-07
JDG Prosthesis, Hip, Femoral Component, Cemented, Metal Orthopedic Class 2 888.3360 2013-12-04
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2019-12-10
NHV System, Water Purification, General Medical Use Gastroenterology, Urology Class 2 876.5665 2021-12-29
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-12-15
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2025-12-15
OAT Implant, Endosseous, Orthodontic Dental Class 2 872.3640 2019-12-10
JAD System, Therapeutic, X-Ray Radiology Class 2 892.5900 2026-01-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-05-10
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-05-10
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2022-04-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2022-04-14
HBF Drills, Burrs, Trephines & Accessories (Compound, Powered) Neurology Class 2 882.4305 2019-12-10
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2020-04-01
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2019-12-10
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2019-12-10
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2022-12-21
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2019-01-23
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2019-01-23
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2025-12-17
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2019-12-10
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2019-12-10
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2015-08-12
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2015-08-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-08-12
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2018-06-15
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2018-06-15
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2022-12-21
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2022-12-21
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2022-12-20
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2024-12-20
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2019-01-17
KIH Dispenser, Cement Orthopedic Class 1 888.4200 2018-12-28
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2017-12-08
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2017-12-08
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2025-12-17
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2019-12-10
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-05-10
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2021-12-29
OAT Implant, Endosseous, Orthodontic Dental Class 2 872.3640 2019-12-10
GFA Blade, Saw, General & Plastic Surgery, Surgical General, Plastic Surgery Class 1 878.4820 2015-08-12
EZD Catheter, Straight Gastroenterology, Urology Class 2 876.5130 2026-01-22
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2020-12-07
MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown Class 3 N/A 2025-07-05
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2020-01-19
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2020-01-19
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2020-01-19
HTW Bit, Drill Orthopedic Class 1 888.4540 2022-12-20
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2022-12-21
GFF Bur, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4820 2015-08-12
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2019-12-10
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2020-12-07
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2024-12-10
EKS File, Pulp Canal, Endodontic Dental Class 1 872.4565 2020-12-07
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2019-12-10
PAO Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented Orthopedic Class 2 888.3660 2021-12-29
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2021-12-29
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2021-12-29

Official Correspondent

No official correspondent registered.

US Agent Details

Mindy McCann Business: Qserve Group US Inc. Email: USagent@qservegroup.com Phone: (424) 2718169

Related Public Records

Same Entity

BGS Beta-Gamma-Service GmbH & Co KG
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3010288357 BGS Beta Gamma Service GmbH & Co KG Saal a.d.Donau Bavaria, DE
3009732568 BGS BETA-GAMMA-SERVICE GMBH & CO KG Wiehl North Rhine-Westphalia, DE

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K030151 Hayes Medical, Inc. CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM 2003-04-10
K153381 Corin U.S.A. Limited Corin Metafix Hip Stem 2016-01-21
K140975 Lima Corporate S.P.A. MASTERSL FEMORAL STEM 2014-06-10
K932222 Dow Corning Wright SLT FEMORAL HEAD 1994-05-27
K910547 Turnkey Intergration USA, Inc. FELDMUEHLE CERAMIC HEAD (12/14 X 28MM) 1991-04-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0006-2019 N/A 3
ENDOLOGIX AFX Endovascular AAA System, Stent Graft System, Rx Only, Sterile EO, REF: BA22-120/I20-40, BA22-100/I20-40, BA22-80/I20-40, BA22-60/I20-40, BA22-40/I20-40, BA22-120/I16-40, BA22-100/I16-40, BA22-80/I16-40, BA22-60/I16-40, BA22-40/I16-40, BA22-120/I13-40, BA22-100/I13-40, BA22-80/I13-40, BA22-60/I13-40, BA22-40/I13-40, BA22-110/I20-30, BA22-90/I20-30, BA22-70/I20-30, BA22-50/I20-30, BA22-110/I16-30, BA22-90/I16-30, BA22-70/I16-30, BA22-50/I16-30, BA22-100/I20-55, BA22-80/I20-55, BA22-100/I16-55, BA22-80/I16-55, BA25-120/I20-40, BA25-100/I20-40, BA25-80/I20-40, BA25-60/I20-40, BA25-40/I20-40, BA25-120/I16-40, BA25-100/I16-40, BA25-80/I16-40, BA25-60/I16-40, BA25-40/I16-40, BA25-120/I13-40, BA25-100/I13-40, BA25-80/I13-40, BA25-60/I13-40, BA25-40/I13-40, BA25-110/I20-30, BA25-90/I20-30, BA25-70/I20-30, BA25-50/I20-30, BA25-110/I16-30, BA25-90/I16-30, BA25-70/I16-30, BA25-50/I16-30, BA25-100/I20-55, BA25-80/I20-55, BA25-100/I16-55, BA25-80/I16-55, BA28-120/I20-40, BA28-100/I20-40, BA28-80/I20-40, BA28-60/I20-40, BA28-40/I20-40, BA28-120/I16-40, BA28-100/I16-40, BA28-80/I16-40, BA28-60/I16-40, BA28-40/I16-40, BA28-120/I13-40, BA28-100/I13-40, BA28-80/I13-40, BA28-60/I13-40, BA28-40/I13-40, BA28-110/I20-30, BA28-90/I20-30, BA28-70/I20-30, BA28-50/I20-30, BA28-110/I16-30, BA28-90/I16-30, BA28-70/I16-30, BA28-50/I16-30, BA28-100/I20-55, BA28-80/I20-55, BA28-100/I16-55, BA28-80/I16-55
Z-0007-2019 N/A 3
ENDOLOGIX AFX2 Bifurcated Endograft System, Stent Graft System, Rx Only, Sterile EO, REF: BEA22-120/I20-40, BEA22-100/I20-40, BEA22-80/I20-40, BEA22-60/I20-40, BEA22-40/I20-40, BEA22-120/I16-40, BEA22-100/I16-40, BEA22-80/I16-40, BEA22-60/I16-40, BEA22-40/I16-40, BEA22-120/I13-40, BEA22-100/I13-40, BEA22-80/I13-40, BEA22-60/I13-40, BEA22-40/I13-40, BEA22-110/I20-30, BEA22-90/I20-30, BEA22-70/I20-30, BEA22-50/I20-30, BEA22-110/I16-30, BEA22-90/I16-30, BEA22-70/I16-30, BEA22-50/I16-30, BEA22-100/I20-55, BEA22-80/I20-55, BEA22-100/I16-55, BEA22-80/I16-55, BEA25-120/I20-40, BEA25-100/I20-40, BEA25-80/I20-40, BEA25-60/I20-40, BEA25-40/I20-40, BEA25-120/I16-40, BEA25-100/I16-40, BEA25-80/I16-40, BEA25-60/I16-40, BEA25-40/I16-40, BEA25-120/I13-40, BEA25-100/I13-40, BEA25-80/I13-40, BEA25-60/I13-40, BEA25-40/I13-40, BEA25-110/I20-30, BEA25-90/I20-30, BEA25-70/I20-30, BEA25-50/I20-30, BEA25-110/I16-30, BEA25-90/I16-30, BEA25-70/I16-30, BEA25-50/I16-30, BEA25-100/I20-55, BEA25-80/I20-55, BEA25-100/I16-55, BEA25-80/I16-55, BEA28-120/I20-40, BEA28-100/I20-40, BEA28-80/I20-40, BEA28-60/I20-40, BEA28-40/I20-40, BEA28-120/I16-40, BEA28-100/I16-40, BEA28-80/I16-40, BEA28-60/I16-40, BEA28-40/I16-40, BEA28-120/I13-40, BEA28-100/I13-40, BEA28-80/I13-40, BEA28-60/I13-40, BEA28-40/I13-40, BEA28-110/I20-30, BEA28-90/I20-30, BEA28-70/I20-30, BEA28-50/I20-30, BEA28-110/I16-30, BEA28-90/I16-30, BEA28-70/I16-30, BEA28-50/I16-30, BEA28-100/I20-55, BEA28-80/I20-55, BEA28-100/I16-55, BEA28-80/I16-55
Z-0008-2019 N/A 3
ENDOLOGIX AFX/AFX2, Proximal (Aortic) Extension Endograft, Rx Only, Sterile EO, AFX Proximal Accessory, Infrarenal Model #/REF: A22-22/C55, A22-22/C75, A22-22/C95, A25-25/C55, A25-25/C75, A25-25/C95, A28-28/C55, A28-28/C75, A28-28/C95, A31-31/C80, A31-31/C100, A34-34/C80, A34-34/C100; Suprarenal Model #/REF: A22-22/C55-O20, A22-22/C75-O20, A22-22/C95-O20, A25-25/C55-O20, A25-25/C75-O20, A25-25/C95-O20, A28-28/C55-O20, A28-28/C75-O20, A28-28/C95-O20, A31-31/C80-O20, A31-31/C100-O20, A34-34/C80-O20, A34-34/C100-O20; AFX Vela, Infrarenal Model #/REF: A22-22/C55V, A22-22/C75V, A22-22/C95V, A25-25/C55V, A25-25/C75V, A25-25/C95V, A28-28/C55V, A28-28/C75V, A28-28/C95V, A31-31/C80V, A31-31/C100V, A34-34/C80V, A34-34/C100V; Suprarenal Model #/REF: A22-22/C55-O20V, A22-22/C75-O20V, A22-22/C95-O20V, A25-25/C55-O20V, A25-25/C75-O20V, A25-25/C95-O20V, A28-28/C55-O20V, A28-28/C75-O20V, A28-28/C95-O20V, A31-31/C80-O20V, A31-31/C100-O20V, A34-34/C80-O20V, A34-34/C100-O20V
Z-0009-2019 N/A 3
ENDOLOGIX AFX/AFX2, Limb (Iliac) Extension Endograft, Rx Only, Sterile EO, AFX Limb Accessory Model #/REF: I16-16/C55, I16-16/C55F, I16-16/C88, I20-13/C70F, I20-13/C88F, I16-16/C55, I16-16/C55F, I16-16/C88, I20-13/C70F, I20-13/C88F; AFX Stand Alone I16-16/C55 SA, I16-16/C55F SA, I16-16/C88 SA, I20-13/C70F SA, I20-13/C88F SA, I20-20/C55 SA, I20-20/C55F SA, IS20-25/C55 SA, IF20-25/C65 SA, IS20-25/C65 SA
Z-0043-2026 Cook Medical Incorporated 3
Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part Numbers ZTA2-P-40-117-W ZTA2-P-40-167 ZTA2-P-40-167-W ZTA2-P-40-217-W ZTA2-P-42-121 ZTA2-P-42-121-W ZTA2-P-42-173 ZTA2-P-42-173-W ZTA2-P-42-225 ZTA2-P-42-225-W ZTA2-P-44-125 ZTA2-P-44-125-W ZTA2-P-44-179 ZTA2-P-44-179-W ZTA2-P-44-233 ZTA2-P-44-233-W ZTA2-P-46-125 ZTA2-P-46-125-W ZTA2-P-46-179 ZTA2-P-46-179-W ZTA2-P-46-233-W ZTA2-PT-40-36-167 ZTA2-PT-40-36-167-W ZTA2-PT-40-36-217 ZTA2-PT-40-36-217-W ZTA2-PT-42-38-173 ZTA2-PT-42-38-173-W ZTA2-PT-42-38-225 ZTA2-PT-42-38-225-W ZTA2-PT-44-40-179 ZTA2-PT-44-40-179-W ZTA2-PT-44-40-233-W ZTA2-PT-46-42-179 ZTA2-PT-46-42-179-W ZTA2-PT-46-42-233 ZTA2-PT-46-42-233-W ZTA2-P-46-233 ZTA2-PT-44-40-233 ZTA2-P-40-217 ZTA2-P-40-117 ZTA2-P-40-167-DEMO ZTA2-P-44-152-W ZTA2-P-40-142 ZTA2-P-44-152 ZTA2-P-40-142-W

Similar Registrations

Registration Number Establishment Name Location
3021386586 LINCOTEK (WUXI) CO., LTD. Wuxi Jiangsu, CN
3005061536 SYMMETRY MEDICAL MANUFACTURING INC CLAYPOOL, IN, US
3007923096 Changzhou Biomet Medical Devices Co., Ltd. Changzhou City Jiangsu, CN
1450662 Isomedix Operations, Inc. Libertyville, IL, US
3020155054 SHALBY ADVANCED TECHNOLOGIES, INC. El Dorado Hills, CA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005562917. Last updated year: 2026. Please use registration number 3005562917 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.