Identity
- Trade Name
- ProChek ID FDA UDI
- Generic Name
- Sterilization packaging tape FDA UDI
- Device Name
- Steam Sterilization Indicator Tape FDA UDI
- Model / Reference
- PIT120 FDA UDI
- Description
- Steam Sterilization Indicator Tape FDA UDI
Identifiers
- Catalog Number
- PIT120-1 FDA UDI
- Primary DI / UDI-DI
- H816PIT1201 FDA UDI
- 510(k) Number
- K951113 FDA UDI
- FDA Product Code
- LRT FDA UDI
- GMDN Term
- Sterilization packaging tape FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.2800 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
No
FDA UDI
Category: Sterilization packaging tape
ProChek ID by Certol International, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sterilization packaging tape.
- Getinge Assured Tape 24mm (Ethylene Oxide) — STERITEC PRODUCT MFG. CO., INC. · Class II
- Getinge Assured Tape 18mm (Ethylene Oxide) — STERITEC PRODUCT MFG. CO., INC. · Class II
- Getinge Sterilization Indicator Tape Ethylene Oxide (EO) — STERITEC PRODUCT MFG. CO., INC. · Class II
- Nev's Ink Inc. — NEVS INK, INC. · Class II
- Getinge Sterilization Indicator Tape 3/4" — STERITEC PRODUCT MFG. CO., INC. · Class II
- Getinge Assured Tape 24mm (Steam) — STERITEC PRODUCT MFG. CO., INC. · Class II
- Getinge Sterilization Indicator Tape 1/2" — STERITEC PRODUCT MFG. CO., INC. · Class II
- SteriTec 1" Green Tape — STERITEC PRODUCT MFG. CO., INC. · Class II
Cleared under the same submission
K951113 also covers:
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
- Certol International, Llc
Sources (1)
- FDA UDI e379b4a7-f9a9-44aa-9a9a-1e3222418585 35 fields · synced May 30, 2026