Identity
- Trade Name
- Coulmed FDA UDI
- Generic Name
- Leg procedure positioner FDA UDI
- Device Name
- Replacement Pads for Ultrafin Surgical Stirrups. 2 Piece Set (Left & Right), Tier II Pressure Relief Pads with Black Skin-Soft Conductive Covering. FDA UDI
- Model / Reference
- AC3900-BP FDA UDI
- Description
- Replacement Pads for Ultrafin Surgical Stirrups. 2 Piece Set (Left & Right), Tier II Pressure Relief Pads with Black Skin-Soft Conductive Covering. FDA UDI
Identifiers
- Catalog Number
- AC3900-BP FDA UDI
- Primary DI / UDI-DI
- 10810087352667 FDA UDI
- FDA Product Code
- CCX FDA UDI
- GMDN Term
- Leg procedure positioner FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.6820 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
Yes
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
Category: Leg procedure positioner
Coulmed by Coulmed Products Group Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Leg procedure positioner.
- Arthrex® — Arthrex, Inc. · Class I
- De Mayo D2® Knee Positioner® — INNOVATIVE MEDICAL PRODUCTS, INC. · Class I
- De Mayo V2E Knee Positioner® — INNOVATIVE MEDICAL PRODUCTS, INC. · Class I
- De Mayo V2E Knee Positioner® — INNOVATIVE MEDICAL PRODUCTS, INC. · Class I
- Proctology support — Reison Medical AB · Class I
- De Mayo D2® Knee Positioner® — INNOVATIVE MEDICAL PRODUCTS, INC. · Class I
- De Mayo D2® Knee Positioner® — INNOVATIVE MEDICAL PRODUCTS, INC. · Class I
- De Mayo D2® Knee Positioner® — INNOVATIVE MEDICAL PRODUCTS, INC. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Coulmed Products Group Llc
Sources (1)
- FDA UDI 90b37edd-9f9c-42f8-a149-a947625d0b9a 34 fields · synced Jun 1, 2026