Identity
- Trade Name
- Mediflex FDA UDI
- Generic Name
- Surgical retractor/retraction system blade, single-use FDA UDI
- Device Name
- Surgical Stays - Skin Hooks EUDAMEDSurgical Stays - 12mm Blunt Hook 2 per pack Skin Hook, Large Blunt 2 per pack FDA UDI
- Model / Reference
- SH-LB-PLS / 4012B-2 EUDAMED4012B-2 FDA UDI
- Description
- Surgical Stays - 12mm Blunt Hook 2 per pack Skin Hook, Large Blunt 2 per pack FDA UDI
Identifiers
- Catalog Number
- 4012B-2 FDA UDI
- Primary DI / UDI-DI
- 08904332600254 EUDAMEDFDA UDI
- Basic UDI-DI
- 089043326SHS0038L EUDAMED
- Unit of Use DI
- 08904332600339 EUDAMED
- FDA Product Code
- GAD FDA UDI
- EMDN Code
- Z12019099 VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY - OTHER EUDAMED
- GMDN Term
- Surgical retractor/retraction system blade, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Surgical retractor/retraction system blade, single-use
Mediflex by Endosys Healthcare India Private Limited — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Endosys Healthcare India Private Limited
Sources (2)
- FDA UDI e46230f8-e128-49fd-bd80-473462ebc26e 35 fields · synced Aug 2, 2026
- EUDAMED 7e9fe24e-853a-4ee2-b50f-f0ce1dc7bd7b 61 fields · synced Aug 2, 2026