Identity
- Trade Name
- PureLife+ Cotton Rolls FDA UDI
- Generic Name
- Dental cotton roll FDA UDI
- Device Name
- PureLife+ Cotton Rolls, #2 Medium, Non-sterile, soft cotton rolls, Made from 100% cotton; no cellulose or rayon fibers and lint-free, Absorb up to 10 times their weight and maintains their shape when wet, #2 Medium (3/8" x 1 1/2") FDA UDI
- Model / Reference
- 1113101 FDA UDI
- Description
- PureLife+ Cotton Rolls, #2 Medium, Non-sterile, soft cotton rolls, Made from 100% cotton; no cellulose or rayon fibers and lint-free, Absorb up to 10 times their weight and maintains their shape when wet, #2 Medium (3/8" x 1 1/2") FDA UDI
Identifiers
- Catalog Number
- 1113101 FDA UDI
- Primary DI / UDI-DI
- D79011131011 FDA UDI
- FDA Product Code
- EFN FDA UDI
- GMDN Term
- Dental cotton roll FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6050 FDA UDI
- Commercial Distribution
- 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental cotton roll
PureLife+ Cotton Rolls by Purelife, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Purelife, Llc
Sources (1)
- FDA UDI adcee6f4-2200-4efc-a147-5e0ca900efa5 35 fields · synced Jun 8, 2026