SION BIOTEXT MEDICAL LTD

FDA Device Registration & Listing · Sderot Southern, IL · Registration 8030128

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
8030128
FEI Number
3006118668
Entity Name
SION BIOTEXT MEDICAL LTD
City/State/Country
Sderot Southern, IL
Establishment Address
3 Eshel St, Sapirim Industrial Park, Sderot Southern 8701002, IL
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
SION BIOTEXT MEDICAL LTD (Owner Number: 8030128)
Owner / Operator Contact Address
3 Eshel St, Sapirim Industrial Park, Sderot, IL-NOTA 8701002, IL
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

CerviLube Surgical Lap sponge/Abdominal sponge(with x-ray detectable) Absorbent Surgical Gauze ball/Peanuts ball(with x-ray detectable) Absorbent Surgical Gauze pad/Gauze swab/Gauze sponge(with x-ray detectable); Non woven ball(with x-ray detectable) Non woven ball(with x-ray detectable) Absorbent Gauze rolls/Gauze slice/Zig-zag gauze(with x-ray detectable) Surgical operation towel(with x-ray detectable) Non woven swab/Non woven pad(with x-ray detectable)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KMJ Lubricant, Patient General Hospital Class 1 880.6375 2010-03-25
KMJ Lubricant, Patient General Hospital Class 1 880.6375 2019-01-31
NEC Bandage, Liquid, Skin Protectant General Hospital Class 1 880.5090 2009-05-04
NAE Dressing, Wound, Hydrogel Without Drug And/Or Biologic General, Plastic Surgery Class 1 878.4022 2025-08-18
ITG Bandage, Cast Physical Medicine Class 1 890.3025 2020-10-05
KMJ Lubricant, Patient General Hospital Class 1 880.6375 2017-10-31
FRO Dressing, Wound, Drug Unknown Class U N/A 2024-06-27
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2017-10-31
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2017-10-31
FRL Fiber, Medical, Absorbent General Hospital Class 1 880.5300 2018-06-26
FTA Light, Surgical, Accessories General, Plastic Surgery Class 2 878.4580 2021-12-20
FQM Bandage, Elastic General Hospital Class 1 880.5075 1996-10-01
GDY Gauze/Sponge, Internal, X-Ray Detectable General, Plastic Surgery Class 1 878.4450 2018-06-26
NAB Gauze / Sponge,Nonresorbable For External Use General, Plastic Surgery Class 1 878.4014 2011-10-26
KOY Degreaser, Skin, Surgical General, Plastic Surgery Class 1 878.4730 2010-10-27
PUI Drape, Surgical, Exempt General, Plastic Surgery Class 2 878.4370 2024-04-29
FRO Dressing, Wound, Drug Unknown Class U N/A 2013-01-29

Official Correspondent

No official correspondent registered.

US Agent Details

Alan Schwartz Business: mdi Consultants, Inc. Email: info@mdiconsultants.com Phone: (516) 4829001

Related Public Records

Same Entity

SION BIOTEXT MEDICAL LTD
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3016603542 Sion Biotext Mexico, S.A.P.I. de C.V Jiutepec Morelos, MX

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K820587 Abco Dealers, Inc. WET PACK LINE OF PRODUCTS 1982-03-26
K150256 Argentum Medical SILVERLON BURN CONTACT DRESSINGS 2015-04-30
K080013 Agfa Healthcare Corporation REGISTRATION AND FUSION 2008-01-17
K042221 Barco NV Barcoview CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM 2004-12-30
K092915 Cedara Software Corp. CEDARA WEBACCESS, MODEL: 2.4 2010-06-23

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-0012-2022 GE Healthcare, LLC 2
Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016 GE Healthcare 2
Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026 CHANGE HEALTHCARE CANADA COMPANY 2
Change Healthcare Radiology Solutions software version 14.2.2

Similar Registrations

Registration Number Establishment Name Location
3003059934 ADVANCED COSMETIC RESEARCH LABORATORIES INC. Chatsworth, CA, US
2022435 Sterigenics U.S., LLC Tustin, CA, US
1222928 Primo Medical Group, INC STOUGHTON, MA, US
2212018 PARKER LABORATORIES, INC. FAIRFIELD, NJ, US
1043214 DEROYAL INDUSTRIES, INC. POWELL, TN, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8030128. Last updated year: 2026. Please use registration number 8030128 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.