Identity
- Trade Name
- E.M Adams co, inc. FDA UDI
- Generic Name
- Surgical soft-tissue manipulation forceps, scissors-like, single-use FDA UDI
- Device Name
- SINGLE INSTRUMENT FDA UDI
- Model / Reference
- 14-3348-1 FDA UDI
- Description
- SINGLE INSTRUMENT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10840200301937 FDA UDI
- 510(k) Number
- K812133 FDA UDI
- FDA Product Code
- FSM FDA UDI
- GMDN Term
- Surgical soft-tissue manipulation forceps, scissors-like, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Category: Surgical soft-tissue manipulation forceps, scissors-like, single-use
E.M Adams co, inc. 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
K812133 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 6a44d9e6-56b7-4e87-bf82-dcc5556b73ed 36 fields · synced May 30, 2026