Identity
- Trade Name
- ELMED FDA UDI
- Generic Name
- Hand-held surgical retractor, reusable FDA UDI
- Device Name
- RETRACTOR, ABD OSULLIVAN-O-CONNOR COMPLETE, (2) BLADES 1-3/4" (4.4CM) WIDE, (1) BLADE 2-3/4" (7CM) WIDE, (2) MOUNTED BLADES 2-3/4" (7CM) DEEP FDA UDI
- Model / Reference
- ST1975400 FDA UDI
- Description
- RETRACTOR, ABD OSULLIVAN-O-CONNOR COMPLETE, (2) BLADES 1-3/4" (4.4CM) WIDE, (1) BLADE 2-3/4" (7CM) WIDE, (2) MOUNTED BLADES 2-3/4" (7CM) DEEP FDA UDI
Identifiers
- Catalog Number
- ST1975400 FDA UDI
- Primary DI / UDI-DI
- 00842180193741 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
- 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
Category: Hand-held surgical retractor, reusable
Elmed by Elmed Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 f333e6d8-8dda-4d2c-acde-196779dfe7b7 35 fields · synced Jun 1, 2026