Identity
- Trade Name
- Crosstex International FDA UDI
- Generic Name
- Sterilization packaging, single-use FDA UDI
- Device Name
- Lead-Free Steam Indicator Tape, 0.47 in X 60 yd (12 mm X 55 m) Roll FDA UDI
- Model / Reference
- STLF12MM FDA UDI
- Description
- Lead-Free Steam Indicator Tape, 0.47 in X 60 yd (12 mm X 55 m) Roll FDA UDI
Identifiers
- Catalog Number
- STLF12MM FDA UDI
- Primary DI / UDI-DI
- 00732224004143 FDA UDI
- 510(k) Number
- K191741 FDA UDI
- FDA Product Code
- JOJ FDA UDI
- GMDN Term
- Sterilization packaging, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.2800 FDA UDI
- Commercial Distribution
- Not 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
Crosstex International by Crosstex International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K191741 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
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- Patterson® — PATTERSON DENTAL SUPPLY, INC.
- Patterson® — PATTERSON DENTAL SUPPLY, 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
- Crosstex International, Inc.
Sources (1)
- FDA UDI c7f3ecb7-710e-4249-a651-c6a2ff0cf93a 37 fields · synced Jun 8, 2026