Identity
- Trade Name
- Pomee FDA UDI
- Generic Name
- Dental rongeur FDA UDI
- Device Name
- Rongeurs Replacment Spring Kit FDA UDI
- Model / Reference
- 711-010 FDA UDI
- Description
- Rongeurs Replacment Spring Kit FDA UDI
Identifiers
- Catalog Number
- 711-010 FDA UDI
- Primary DI / UDI-DI
- G1577110100 FDA UDI
- FDA Product Code
- EMH FDA UDI
- GMDN Term
- Dental rongeur FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental rongeur
Pomee by Pomee Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental rongeur.
- STOMA® — Storz am Mark GmbH · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class I
- ZOLL-DENTAL — Zoll-Dental · Class I
- Power Dental USA — Power Dental USA, Inc. · Class I
- ACE — ACE SURGICAL SUPPLY CO., INC. · Class I
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
- STOMA® — Storz am Mark GmbH · Class I
- BMT Medizintechnik GmbH — BMT Medizintechnik GmbH · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pomee Corporation
Sources (1)
- FDA UDI 038c679f-2386-4c49-921f-8b27f4ec4393 34 fields · synced May 30, 2026