Identity
- Trade Name
- Steril Peel FDA UDI
- Generic Name
- Sterilization packaging, single-use FDA UDI
- Device Name
- STERIL-PEEL TUBING/ROLL 4" X 656' FDA UDI
- Model / Reference
- 221434RX FDA UDI
- Description
- STERIL-PEEL TUBING/ROLL 4" X 656' FDA UDI
Identifiers
- Primary DI / UDI-DI
- D830221434RX9 FDA UDI
- 510(k) Number
- K953829 FDA UDI
- FDA Product Code
- KCT 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Sterilization packaging, single-use
Steril Peel by AMD Medicom Inc — 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
K953829 also covers:
- Element Self Sealing Sterilization Pouch — AMD Medicom Inc
- Element Self Sealing Sterilization Pouch — AMD Medicom Inc
- Element Self Sealing Sterilization Pouch — AMD Medicom Inc
- Element Self Sealing Sterilization Pouch — AMD Medicom Inc
- Generic — AMD Medicom Inc
- Generic — AMD Medicom Inc
- Generic — AMD Medicom Inc
- Generic — AMD Medicom Inc
- Generic — AMD Medicom Inc
- Generic — AMD Medicom Inc
- Generic — AMD Medicom Inc
- Oasis — AMD Medicom Inc
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
- AMD Medicom Inc
Sources (1)
- FDA UDI 0beba517-b285-4c8f-8142-4156af36715a 35 fields · synced Jun 1, 2026