Identity
- Trade Name
- MediChoice FDA UDI
- Generic Name
- Limb/torso/head restraint, reusable FDA UDI
- Device Name
- Mitts Soft Hand One Size Fits All Pair No Finger Separators Breathable Cover Polystyrene Bead Fill Hook And Loop Wrist Closure Not Made With Natural Rubber Latex MediChoice FDA UDI
- Model / Reference
- MTT2810 FDA UDI
- Description
- Mitts Soft Hand One Size Fits All Pair No Finger Separators Breathable Cover Polystyrene Bead Fill Hook And Loop Wrist Closure Not Made With Natural Rubber Latex MediChoice FDA UDI
Identifiers
- Primary DI / UDI-DI
- 50885632136663 FDA UDI
- 510(k) Number
- K110377 FDA UDI
- FDA Product Code
- FMQ FDA UDI
- GMDN Term
- Limb/torso/head restraint, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6760 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Limb/torso/head restraint, reusable
MediChoice by Owens & Minor Distribution, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Limb/torso/head restraint, reusable.
- E.M Adams co, inc. — E.M. Adams · Class I
- E.M. Adams Co, Inc. — E.M. Adams · Class I
- E.M. ADAMS CO, INC — E.M. Adams · Class I
- POSEY — POSEY PRODUCTS, LLC · Class I
- Morrison Medical — MORRISON MEDICAL, LTD · Class I
- Restraint strap — Skytron, LLC · Class I
- E.M Adams co, inc. — E.M. Adams · Class I
- MORRISON MEDICAL — MORRISON MEDICAL, LTD · Class I
Cleared under the same submission
K110377 also covers:
- Protective Mitts — MEDI-TECH INTERNATIONAL CORPORATION
- Protective Mitts — MEDI-TECH INTERNATIONAL CORPORATION
- Protective Mitts — MEDI-TECH INTERNATIONAL CORPORATION
- Protective Mitts — MEDI-TECH INTERNATIONAL CORPORATION
- Protective Mitts — MEDI-TECH INTERNATIONAL CORPORATION
- Protective Mitts — MEDI-TECH INTERNATIONAL CORPORATION
- Protective Pediatric Mitts — MEDI-TECH INTERNATIONAL CORPORATION
- Protective Pediatric Mitts — MEDI-TECH INTERNATIONAL CORPORATION
- Protective Pediatric Mitts — MEDI-TECH INTERNATIONAL CORPORATION
- MediChoice — OWENS & MINOR DISTRIBUTION, INC.
- MediChoice — OWENS & MINOR DISTRIBUTION, INC.
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
- Owens & Minor Distribution, Inc.
Sources (1)
- FDA UDI 3f68f227-e801-4dfe-8213-669c9dea7a8d 34 fields · synced May 31, 2026