Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007663067

FEI Number

3007663067

Entity Name

Systagenix Wound Management Manufacturing Limited

City/State/Country

North Yorkshire, GB

Establishment Address

Airebank Mill, Gargrave, North Yorkshire BD23 3RX, GB

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Systagenix Wound Management Manufacturing Limited (Owner Number: 10028771)

Owner / Operator Contact Address

Airebank Mill, Gargrave, North Yorkshire, GB-NYK BD23 3RX, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Pitch Patch Tissue Reinforcement 30mm x 20mm. 102-1090, Pitch Patch Tissue Reinforcement 35mm x 25mm. 102-1091 Tender Care Hydrogel Pad MediHoney HCS / HCS Burn Dressing TekBrace Solo Poly-Tape, Infinity Lock, AchilloCordPLUS, SIC Graft, FORCEWEB CC-Hook Susol® Scissors Iris Fine Point Straight 11.5cm, Susol® Scissors Lister Bandage 18.5cm, Susol® Nipper Thwaites Nail 14cm Susol® Forceps Artery Halstead Mosquito Curved 12.5cm Susol® Forceps Dissecting Iris Straight 1:2 Teeth 11.5cm Susol® Forceps Dissecting Adson Serrated 13cm Susol® Forceps Dissecting Iris Straight Serrated 11.5cm Susol® Forceps Rampleys Sponge Holding 18cm Susol® Forceps Dissecting Adson 1:2 Teeth 13cm MediHoney Hydrogel Susol® Nipper General Curved 13cm, Susol® Nipper Ingrown Nail 14cm Infinity-Lock Button System Xtrasorb Gentle Cutimed Sorbion Border Gentell Hydrogel Acute Surgical Incision Dressings ActiV.A.C.Canister with Gel ActiV.A.C.300ml Canister with Gel Fastlok Susol® Probe Flat Head Swan Neck 12.5cm, Susol® Blacks File Double Ended Micro with Round Probe 14cm Susol® Standard Suture Pack Dr Scholls Blister Cushions Malleable Probe, Rigid Probe Susol® Diamond Bur Bud 3, Susol® Diamond Bur Bud 2 Susol® Basic Care Pack Susol® Partial Nail Avulsion Procedure Pack Silvercel Non-Adherent Antimicrobial Alginate Dressing Susol® Micro Curette Double Ended with hole, Susol® House Curette Malleable Double Ended 2mm/3mm Scoops 180mm Poly-Tape 30mm x 800mm Susol® Laryngeal Handle & Mirror Size 25mm Silvercel Antimicrobial Alginate Dressing

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2021-09-27
NTC	Nursing Pad, Hydrogel	General Hospital	Class 1	880.5630	2020-09-25
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2022-04-28
QUW	Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament	General, Plastic Surgery	Class 2	878.3300	2025-08-14
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2025-08-14
OWX	Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon	General, Plastic Surgery	Class 2	878.3300	2025-08-14
QUW	Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament	General, Plastic Surgery	Class 2	878.3300	2023-01-05
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2023-01-05
OWX	Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon	General, Plastic Surgery	Class 2	878.3300	2023-01-05
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2019-11-25
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2025-09-17
LYC	Bone Grafting Material, Synthetic	Dental	Class 2	872.3930	2026-02-09
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2025-09-17
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2020-03-06
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	2025-09-17
GXP	Methyl Methacrylate For Cranioplasty	Neurology	Class 2	882.5300	2026-02-09
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2026-02-09
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2019-11-25
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2009-09-17
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2013-01-31
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2023-11-30
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2013-02-15
MED	Sterilant, Medical Devices	General Hospital	Class 2	880.6885	2009-05-01
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-11-25
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2026-05-06
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2026-05-06
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2025-09-17
OVN	Suture Kit	General, Plastic Surgery	Class 2	878.4830	2025-09-17
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2020-09-25
HXB	Probe	Orthopedic	Class 1	888.4540	2022-11-14
OKO	Negative Pressure Wound Therapy Non-Powered Suction Apparatus	General, Plastic Surgery	Class 2	878.4683	2018-12-21
GFF	Bur, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4820	2025-09-17
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2013-02-20
MBB	Bone Cement, Antibiotic	Orthopedic	Class 2	888.3027	2013-02-20
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2025-09-17
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2010-11-05
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2009-03-05
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2009-06-26
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2025-09-17
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2010-11-05
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-11-25
KMF	Bandage, Liquid	General Hospital	Class 1	880.5090	2018-12-21
KAI	Mirror, Ent	Ear, Nose, Throat	Class 1	874.4420	2025-09-17
MED	Sterilant, Medical Devices	General Hospital	Class 2	880.6885	2009-05-01
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2010-11-05

Official Correspondent

Libby Morrison

US Agent Details

Jason Troutman Business: Biomed Laboratories Inc Email: jason.troutman@mativ.com Phone: (949) 4197005

Related Public Records

Same Entity

Systagenix Wound Management Manufacturing Limited

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K220540	Covidien	ProGrip Self-Gripping Polypropylene Mesh	2022-09-22
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30
K052493	Steiner Laboratories	SOCKET GRAFT	2006-06-09
K851170	The Huxley Instrument Corp.	DISSECTING TWEEZER #283-72PCS. SS 410	1985-04-25
K821248	Conphar, Inc.	ROCHESTER PEAN FORCEPS	1982-05-28

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007663067. Last updated year: 2026. Please use registration number 3007663067 when referencing this establishment in official correspondence.