Identity
- Trade Name
- Integra® Miltex® FDA UDI
- Generic Name
- Endometrial biopsy kit FDA UDI
- Device Name
- Integra® Miltex® Firmflex Endometrial Biopsy Cannula FDA UDI
- Model / Reference
- 30-3012 FDA UDI
- Description
- Integra® Miltex® Firmflex Endometrial Biopsy Cannula FDA UDI
Identifiers
- Catalog Number
- 30-3012 FDA UDI
- Primary DI / UDI-DI
- 10381780169956 FDA UDI
- 510(k) Number
- K020628 FDA UDI
- FDA Product Code
- HHK FDA UDI
- GMDN Term
- Endometrial biopsy kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1175 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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: Endometrial biopsy kit
Integra® Miltex® by Integra LifeSciences Production Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- Integra LifeSciences Production Corporation
Sources (1)
- FDA UDI 434d446a-ea17-40c6-9741-63eca1ed1b04 36 fields · synced Jun 9, 2026