Identity
- Trade Name
- Midmark FDA UDI
- Generic Name
- Leg procedure positioner FDA UDI
- Device Name
- The Standard Knee Crutches (without accessory receiver) are designed to swivel to provide leg support for extended procedures where fatigue is a factor or when the patient lacks sufficient leg strength or control. FDA UDI
- Model / Reference
- 9A410001 FDA UDI
- Description
- The Standard Knee Crutches (without accessory receiver) are designed to swivel to provide leg support for extended procedures where fatigue is a factor or when the patient lacks sufficient leg strength or control. FDA UDI
Identifiers
- Catalog Number
- 9A410001 FDA UDI
- Primary DI / UDI-DI
- 00841709113178 FDA UDI
- FDA Product Code
- FRK FDA UDIGBB FDA UDI
- GMDN Term
- Leg procedure positioner FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6140 FDA UDI878.4960 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Leg procedure positioner
Midmark by Midmark Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- 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 |
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Manufacturer
- Manufacturer
- Midmark Corporation
Sources (1)
- FDA UDI 4d16c888-ca5d-4cd1-9b80-f60f73c2c076 35 fields · synced Jun 8, 2026