Identity
- Trade Name
- Strata-G™ Sectional Matrix Bands EUDAMEDStrata-G™ FDA UDI
- Generic Name
- Dental matrix band, single-use FDA UDI
- Device Name
- Bands Family EUDAMEDStrata-G™ Matrix Bands: 100 Count FDA UDI
- Model / Reference
- SG050 EUDAMEDFDA UDI
- Description
- Strata-G™ Matrix Bands: 100 Count FDA UDI
Identifiers
- Catalog Number
- SG050 FDA UDI
- Primary DI / UDI-DI
- 10810038090495 EUDAMEDFDA UDI
- Basic UDI-DI
- 081003809BandsTFXZ EUDAMED
- Direct Marketing DI
- 10810038090495 EUDAMED
- FDA Product Code
- JEP FDA UDI
- EMDN Code
- Q01010401 PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY EUDAMED
- GMDN Term
- Dental matrix band, single-use 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Strata-G™ Sectional Matrix Bands by Garrison Dental Solutions LLC — 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 | 081003809BandsTFXZ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Garrison Dental Solutions LLC
- EUDAMED SRN
- US-MF-000004112
- Authorised Representative
- Eurolink Europe Compliance Limited IE-AR-000002852
Sources (2)
- EUDAMED cb52b7a2-3f6d-4f5f-a3f9-6b47e0790bf9 61 fields · synced Jul 12, 2026
- FDA UDI 0e8418b4-e999-4f0d-8b67-d4ce5c2c8e0b 35 fields · synced May 30, 2026