Identity
- Trade Name
- Integra® Miltex® FDA UDI
- Generic Name
- Vaginal dilator FDA UDI
- Device Name
- Integra® Miltex® SILICONE VAGINAL DILATOR SET LARGE SET OF 4 SIZES FDA UDI
- Model / Reference
- 30-3001 FDA UDI
- Description
- Integra® Miltex® SILICONE VAGINAL DILATOR SET LARGE SET OF 4 SIZES FDA UDI
Identifiers
- Catalog Number
- 30-3001 FDA UDI
- Primary DI / UDI-DI
- 10381780169918 FDA UDI
- 510(k) Number
- K003380 FDA UDI
- FDA Product Code
- HDX FDA UDI
- GMDN Term
- Vaginal dilator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.3900 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Vaginal dilator
Integra® Miltex® by Integra LifeSciences Production Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vaginal dilator.
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Cleared under the same submission
K003380 also covers:
- Bioteque America, Inc. — BIOTEQUE AMERICA, INC.
- Bioteque America, Inc. — BIOTEQUE AMERICA, INC.
- Bioteque America, Inc. — BIOTEQUE AMERICA, INC.
- Bioteque America, Inc. — BIOTEQUE AMERICA, INC.
- Bioteque America, Inc. — BIOTEQUE AMERICA, INC.
- Bioteque America, Inc. — BIOTEQUE AMERICA, INC.
- Bioteque America, Inc. — BIOTEQUE AMERICA, INC.
- Bioteque America, Inc. — BIOTEQUE AMERICA, INC.
- Bioteque America, Inc. — BIOTEQUE AMERICA, INC.
- Bioteque America, Inc. — BIOTEQUE AMERICA, INC.
- Bioteque America, Inc. — BIOTEQUE AMERICA, INC.
- Integra® Miltex® — Integra LifeSciences Production Corporation
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 c6384eab-fe40-41a1-ba7c-82388e7ee09e 36 fields · synced Jun 9, 2026