Identity
- Trade Name
- Bioteque America, Inc. FDA UDI
- Generic Name
- Vaginal dilator FDA UDI
- Device Name
- Vaginal Dilator set-C, SET DT-C FDA UDI
- Model / Reference
- DT-C FDA UDI
- Description
- Vaginal Dilator set-C, SET DT-C FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810142352314 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Vaginal dilator
Bioteque America, Inc. by Bioteque America, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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.
- Integra® Miltex® — Integra LifeSciences Production Corporation
- 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 |
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Manufacturer
- Manufacturer
- Bioteque America, Inc.
Sources (1)
- FDA UDI 54ed9773-f7fc-4d37-9648-a9d48a11cdd3 34 fields · synced Jun 1, 2026