Identity
- Trade Name
- ELMED FDA UDI
- Generic Name
- Hand-held surgical retractor, reusable FDA UDI
- Device Name
- US ARMY / NAVY INSULATED RETRACTOR SET OF 2, 8 1/2" OVERALL LENGTH FDA UDI
- Model / Reference
- ST153900I FDA UDI
- Description
- US ARMY / NAVY INSULATED RETRACTOR SET OF 2, 8 1/2" OVERALL LENGTH FDA UDI
Identifiers
- Catalog Number
- ST153900I FDA UDI
- Primary DI / UDI-DI
- 00842180192089 FDA UDI
- FDA Product Code
- GAD FDA UDI
- GMDN Term
- Hand-held surgical retractor, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Elmed by Elmed Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Elmed Incorporated
Sources (1)
- FDA UDI 02983dbe-ca6d-4bdb-ac36-61c8eccf02c7 36 fields · synced Jun 6, 2026