Identity
- Trade Name
- Henry Schein FDA UDI
- Generic Name
- Sterilization packaging, single-use FDA UDI
- Device Name
- Lead Free Steam Indicator Tape 1" FDA UDI
- Model / Reference
- 5701509 FDA UDI
- Description
- Lead Free Steam Indicator Tape 1" FDA UDI
Identifiers
- Catalog Number
- 5701509 FDA UDI
- Primary DI / UDI-DI
- 00304040115459 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
- 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, single-use
Henry Schein by Henry Schein, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Sterilization packaging, single-use.
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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.
- 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 |
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Manufacturer
- Manufacturer
- Henry Schein, Inc.
Sources (1)
- FDA UDI c2c0f24c-3432-4806-a39c-6f126ef800a9 35 fields · synced Jun 6, 2026