Identity
- Trade Name
- Self Retaining Retr 4" sharp EUDAMEDgSource FDA UDI
- Generic Name
- Self-retaining surgical retractor, reusable FDA UDI
- Device Name
- Elevator EUDAMEDSelf Retaining Retr 4" sharp FDA UDI
- Model / Reference
- gS 38.5170 EUDAMEDFDA UDI
- Description
- Self Retaining Retr 4" sharp FDA UDI
Identifiers
- Catalog Number
- gS 38.5170 FDA UDI
- Primary DI / UDI-DI
- 00840314216182 EUDAMEDFDA UDI
- Basic UDI-DI
- 08403142RETRACTDISTRACTDL EUDAMED
- Direct Marketing DI
- 00840314216182 EUDAMED
- FDA Product Code
- GAD FDA UDI
- EMDN Code
- L03140101 SELF-STATIC SPREADERS, REUSABLE EUDAMED
- GMDN Term
- Self-retaining surgical retractor, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Self-retaining surgical retractor, reusable
gSource by Gsource, Llc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Self-retaining surgical retractor, reusable.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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
- Gsource, Llc.
Sources (2)
- FDA UDI 1560f091-fdfe-454d-b0aa-1e90b3249700 34 fields · synced Jun 18, 2026
- EUDAMED d69d69fe-f5a5-4213-b98b-2ea95ac80f33 61 fields · synced Jun 18, 2026