Identity
- Trade Name
- E.M. Adams Company FDA UDI
- Generic Name
- Limb/torso/head restraint, reusable FDA UDI
- Device Name
- ELBOW SPLINT FDA UDI
- Model / Reference
- EP28-0301SU-1 FDA UDI
- Description
- ELBOW SPLINT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10840200314517 FDA UDI
- 510(k) Number
- K971948 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
No
FDA UDI
Category: Limb/torso/head restraint, reusable
E.M. Adams Company by E.M. Adams — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K971948 also covers:
- E.M Adams co, inc. — E.M. Adams
- E.M Adams co, inc. — E.M. Adams
- E.M Adams co, inc. — E.M. Adams
- E.M Adams co, inc. — E.M. Adams
- E.M Adams co, inc. — E.M. Adams
- E.M Adams co, inc. — E.M. Adams
- E.M Adams co, inc. — E.M. Adams
- E.M Adams co, inc. — E.M. Adams
- E.M Adams co, inc. — E.M. Adams
- E.M Adams co, inc. — E.M. Adams
- E.M Adams co, inc. — E.M. Adams
- E.M. ADAMS CO, INC — E.M. Adams
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
- E.M. Adams
Sources (1)
- FDA UDI c67448cf-b59a-4819-a72f-6c55df782f64 36 fields · synced May 30, 2026