Identity
- Trade Name
- Integra® Miltex® FDA UDI
- Generic Name
- Sterilizer/disinfector rack instrument-holding insert, reusable FDA UDI
- Device Name
- Integra® Miltex® Replacement mat for 7" X 11" Tray FDA UDI
- Model / Reference
- 3200100A FDA UDI
- Description
- Integra® Miltex® Replacement mat for 7" X 11" Tray FDA UDI
Identifiers
- Catalog Number
- 3200100A FDA UDI
- Primary DI / UDI-DI
- 10381780171867 FDA UDI
- FDA Product Code
- KCT FDA UDI
- GMDN Term
- Sterilizer/disinfector rack instrument-holding insert, reusable 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Sterilizer/disinfector rack instrument-holding insert, reusable
Integra® Miltex® by Integra LifeSciences Production Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sterilizer/disinfector rack instrument-holding insert, reusable.
- Case Medical, Inc — CASE MEDICAL INC · Class I
- Premium Plus — Premium Plus International Limited · Class I
- Premium Plus — Premium Plus International Limited · Class I
- Premium Plus — Premium Plus International Limited · Class I
- Premium Plus — Premium Plus International Limited · Class I
- Case Medical, Inc — CASE MEDICAL INC · Class I
- KOMET Bur Blocks — Gebr. Brasseler GmbH & Co. KG · Class I
- SCHWERT — A. Schweickhardt GmbH & Co. KG · Class I
Cleared under the same submission
K012105 also covers:
- Gyrus ACMI — Gyrus Acmi, Inc.
- Gyrus ACMI — Gyrus Acmi, Inc.
- Gyrus ACMI — Gyrus Acmi, Inc.
- SlimLine — Gyrus Acmi, Inc.
- Integra® Miltex® — Integra LifeSciences Production Corporation
- Integra® Miltex® — Integra LifeSciences Production Corporation
- Integra® Miltex® — Integra LifeSciences Production Corporation
- DYONICS — Smith & Nephew, 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
- Integra LifeSciences Production Corporation
Sources (1)
- FDA UDI 40dfb5bb-8422-4f38-bfbb-0d987c24f14f 36 fields · synced Jun 9, 2026