Identity
- Trade Name
- Gripper™ Soft Copper Band FDA UDI
- Generic Name
- Dental matrix band, single-use FDA UDI
- Device Name
- Size 5 Gripper™ Soft Copper Band Refill (Pkg. of 10 pcs.) FDA UDI
- Model / Reference
- S702-05 FDA UDI
- Description
- Size 5 Gripper™ Soft Copper Band Refill (Pkg. of 10 pcs.) FDA UDI
Identifiers
- Catalog Number
- S702-05 FDA UDI
- Primary DI / UDI-DI
- 10810000527363 FDA UDI
- FDA Product Code
- KCQ FDA UDI
- GMDN Term
- Dental matrix band, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6570 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 6.35 Millimeter FDA UDIHeight — 12.10 Millimeter FDA UDI
Gripper™ Soft Copper Band by Parkell, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Parkell, Inc.
Sources (1)
- FDA UDI 5cf83dc2-b570-420a-8f6b-9d5853db5e53 37 fields · synced Jun 1, 2026