Identity
- Trade Name
- Integra® Miltex® FDA UDI
- Generic Name
- Uterine sound, single-use FDA UDI
- Device Name
- Integra® Miltex® Disposable Fundus Sound, 8-1/2" FDA UDI
- Model / Reference
- 30-5003 FDA UDI
- Description
- Integra® Miltex® Disposable Fundus Sound, 8-1/2" FDA UDI
Identifiers
- Catalog Number
- 30-5003 FDA UDI
- Primary DI / UDI-DI
- 10381780441595 FDA UDI
- FDA Product Code
- HHM FDA UDI
- GMDN Term
- Uterine sound, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 884.4530 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Uterine sound, single-use
Integra® Miltex® by Integra LifeSciences Production Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Uterine sound, single-use.
- Sklar® — Sklar Corporation · Class I
- Instrapac — ROBINSON HEALTHCARE LIMITED · Class I
- HNM MEDICAL — HNM STAINLESS, LLC. · Class I
- Gynex — GYNEX CORPORATION · Class I
- Gynex — GYNEX CORPORATION · Class I
- Gynex — GYNEX CORPORATION · Class I
- Centurion — Centurion Medical Products · Class II
- Bioteque Taiwan Ltd. — Bioteque Taiwan Ltd. · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Integra LifeSciences Production Corporation
Sources (1)
- FDA UDI 7a11ed03-a1b6-45c2-85ea-48dce889ca50 35 fields · synced Jun 9, 2026