Identity
- Trade Name
- HSM EUDAMEDHenry Schein FDA UDI
- Generic Name
- Dental rongeur FDA UDI
- Device Name
- Holding Instruments EUDAMEDRongeur Friedman FDA UDI
- Model / Reference
- 1007991 EUDAMEDFDA UDITF-227 (HS) EUDAMED
- Description
- Rongeur Friedman FDA UDI
Identifiers
- Catalog Number
- 1007991 FDA UDI
- Primary DI / UDI-DI
- 00304040135914 EUDAMED00304040046654 FDA UDI
- Basic UDI-DI
- B-00304040135914 EUDAMED
- FDA Product Code
- EKD FDA UDI
- EMDN Code
- L091399 ORTHOPAEDIC SURGERY FORCEPS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Dental rongeur FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental rongeur
Henry Schein by Henry Schein, Inc. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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- ACE — ACE SURGICAL SUPPLY CO., INC. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Henry Schein, Inc.
Sources (2)
- FDA UDI 98f7c717-fe9c-4706-964c-f1cc89de1150 34 fields · synced Jun 19, 2026
- EUDAMED 9b724b93-02a0-4888-9a37-d88557abeda9 61 fields · synced Jun 19, 2026