Identity
- Trade Name
- PureLife+ Sterilization Pouches FDA UDI
- Generic Name
- Sterilization container liner FDA UDI
- Device Name
- PureLife+ Sterilization Pouches, 3 1/2" x 5 1/4", Self-sealing sterilization pouches, Class 4 dual indicators, Thumb notch for easy opening FDA UDI
- Model / Reference
- 1192003 FDA UDI
- Description
- PureLife+ Sterilization Pouches, 3 1/2" x 5 1/4", Self-sealing sterilization pouches, Class 4 dual indicators, Thumb notch for easy opening FDA UDI
Identifiers
- Catalog Number
- 1192003 FDA UDI
- Primary DI / UDI-DI
- D79011920031 FDA UDI
- 510(k) Number
- K172280 FDA UDI
- FDA Product Code
- FRG FDA UDI
- GMDN Term
- Sterilization container liner FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6850 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Sterilization container liner
PureLife+ Sterilization Pouches by Purelife, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K172280 also covers:
- iSmile — ISMILE DENTAL PRODUCTS INC.
- iSmile — ISMILE DENTAL PRODUCTS INC.
- iSmile — ISMILE DENTAL PRODUCTS INC.
- iSmile — ISMILE DENTAL PRODUCTS INC.
- iSmile — ISMILE DENTAL PRODUCTS INC.
- iSmile — ISMILE DENTAL PRODUCTS INC.
- iSmile — ISMILE DENTAL PRODUCTS INC.
- iSmile — ISMILE DENTAL PRODUCTS INC.
- iSmile — ISMILE DENTAL PRODUCTS INC.
- Plasdent Clear Protection Sterilization Pouch — PLASDENT CORP.
- Plasdent Clear Protection Sterilization Pouch — PLASDENT CORP.
- Plasdent Clear Protection Sterilization Pouch — PLASDENT CORP.
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 II | Pending data |
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Manufacturer
- Manufacturer
- Purelife, Llc
Sources (1)
- FDA UDI cd763e0b-6ff8-4e30-ab25-523d0c6b2a03 37 fields · synced Jun 8, 2026