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C-Type Release Module/10 Pk Hvy Force
EUDAMEDFDA UDIClass I (EU MDR)
Ref 715-2021Model 715-*
Identity
- Trade Name
- C-TYPE RELEASE MODULE/10 PK HVY FORCE EUDAMEDC-Type Release Module FDA UDI
- Generic Name
- Orthodontic extraoral headgear FDA UDI
- Device Name
- RELEASE MODULE EUDAMEDC-TYPE RELEASE MODULE HVY FORCE FDA UDI
- Model / Reference
- 715-* EUDAMED715-2021 EUDAMEDFDA UDI
- Description
- C-TYPE RELEASE MODULE HVY FORCE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889989059892 EUDAMEDFDA UDI
- Basic UDI-DI
- 0889989-ExOrl_HG_Strap-TP EUDAMED
- FDA Product Code
- DZB FDA UDI
- EMDN Code
- Q010401 ORTHODONTIC FACE BOWS EUDAMED
- GMDN Term
- Orthodontic extraoral headgear FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.5500 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
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
C-Type Release Module/10 Pk Hvy Force by Ormco Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0889989-ExOrl_HG_Strap-TP | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ormco Corporation
- EUDAMED SRN
- US-MF-000038085
- Authorised Representative
- KERR ITALIA SRL IT-AR-000007600
Sources (2)
- EUDAMED d95d97e4-10d6-45d6-8516-d2f8162bd4ce 61 fields · synced Jun 18, 2026
- FDA UDI e6bb96ec-e994-41c7-8476-c603307be417 34 fields · synced May 30, 2026