Identity
- Trade Name
- De Mayo Universal Distractor® FDA UDI
- Generic Name
- Orthopaedic knee/leg holder liner FDA UDI
- Device Name
- Sample Sterile Pressure Protector Pad® for De Mayo Universal Distractor® FDA UDI
- Model / Reference
- 907-GP-10.1 FDA UDI
- Description
- Sample Sterile Pressure Protector Pad® for De Mayo Universal Distractor® FDA UDI
Identifiers
- Catalog Number
- 907-GP-10.1 FDA UDI
- Primary DI / UDI-DI
- 00696588005973 FDA UDI
- FDA Product Code
- FMP FDA UDI
- GMDN Term
- Orthopaedic knee/leg holder liner FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6450 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthopaedic knee/leg holder liner
De Mayo Universal Distractor® by Innovative Medical Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic knee/leg holder liner.
- Arthrex® — Arthrex, Inc. · Class I
- Thigh Holder Pad — Aspen Surgical Products, Inc. · Class I
- FERKEL — Smith & Nephew, Inc. · Class I
- Alvarado® Knee Support — Zimmer Orthopaedic Surgical Products · Class I
- Alvarado — Zimmer Orthopaedic Surgical Products · Class I
- Leg Comfort Pad — Aspen Surgical Products, Inc. · Class I
- Hermanator Knee Positioning Pad — Aspen Surgical Products, Inc. · Class I
- KNEE FOOT SUPPORT LINER — Mizuho Orthopedic Systems, 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 |
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Manufacturer
- Manufacturer
- Innovative Medical Products, Inc.
Sources (1)
- FDA UDI 5605b04c-2a6b-4797-b33e-ca036c2d94d9 34 fields · synced May 31, 2026