Identity
- Trade Name
- MediChoice FDA UDI
- Generic Name
- Limb/torso/head restraint, reusable FDA UDI
- Device Name
- Mitts Double Essential Secure One Size Fits All Pair No Finger Separators Double-Padded Cotton Polyester And Polyester Fiberfill Hook And Loop Wrist Closure Optional 48.75 Inch Strap Not Made With Natural Rubber Latex MediChoice FDA UDI
- Model / Reference
- MTT2819 FDA UDI
- Description
- Mitts Double Essential Secure One Size Fits All Pair No Finger Separators Double-Padded Cotton Polyester And Polyester Fiberfill Hook And Loop Wrist Closure Optional 48.75 Inch Strap Not Made With Natural Rubber Latex MediChoice FDA UDI
Identifiers
- Primary DI / UDI-DI
- 50885632133280 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 7e194c32-d071-4488-8b9d-5af3664c5b1f 34 fields · synced May 30, 2026