Identity
- Trade Name
- PCL Retractor FDA UDI
- Generic Name
- Leg procedure positioner FDA UDI
- Device Name
- PCL Retractor FDA UDI
- Model / Reference
- N/A FDA UDI
- Description
- PCL Retractor FDA UDI
Identifiers
- Catalog Number
- BIO-1-1083 FDA UDI
- Primary DI / UDI-DI
- B046BIO110830 FDA UDI
- FDA Product Code
- KIL FDA UDIJEB FDA UDI
- GMDN Term
- Leg procedure positioner FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI878.4950 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
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
No
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: Leg procedure positioner
PCL Retractor by Signal Medical Corp. — 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
- Signal Medical Corp.
Sources (1)
- FDA UDI 3e28449f-d129-4a02-a1e7-fcc83590a5d2 35 fields · synced May 30, 2026