Identity
- Trade Name
- 2 INCH CLEAR CONT NYL FILM (0002) FDA UDI
- Generic Name
- Sterilization packaging, single-use FDA UDI
- Device Name
- 2 INCH CLEAR CONT NYL FILM (0002) FDA UDI
- Model / Reference
- 01I0002 FDA UDI
- Description
- 2 INCH CLEAR CONT NYL FILM (0002) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00303620000109 FDA UDI
- 510(k) Number
- K870147 FDA UDI
- FDA Product Code
- FRG FDA UDI
- GMDN Term
- Sterilization packaging, single-use 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Width — 2 Inch FDA UDI
Category: Sterilization packaging, single-use
2 Inch Clear Cont Nyl Film (0002) by Septodont — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sterilization packaging, single-use.
- Dental City — ICP, INC. · Class II
- Essentials by 3D Dental — 3D DENTAL DESIGNS AND DEVELOPMENT, LLC · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- VIVIT Supply — Vivit Supply LLC · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Arjo Wiggins Medical, Inc. — Sterimed, Inc. · Class II
- Patterson® — PATTERSON DENTAL SUPPLY, INC. · Class II
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C. · Class II
Cleared under the same submission
K870147 also covers:
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Septodont
Sources (1)
- FDA UDI 622fd8a5-abe2-459b-a5c7-de51b1cc9ada 37 fields · synced May 30, 2026