Identity
- Trade Name
- Avalign FDA UDI
- Generic Name
- Fixed-diameter cervical dilator, reusable FDA UDI
- Device Name
- Hegar Uterine Dilators FDA UDI
- Model / Reference
- VM57-3148 FDA UDI
- Description
- Hegar Uterine Dilators FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190776212001 FDA UDI
- FDA Product Code
- HDQ FDA UDI
- GMDN Term
- Fixed-diameter cervical dilator, reusable 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
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Fixed-diameter cervical dilator, reusable
Avalign by AVALIGN TECHNOLOGIES, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fixed-diameter cervical dilator, reusable.
- Surgical — TIMESCO HEALTHCARE LIMITED · Class I
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- Kleegman Stainless Steel Dilator — MEDGYN PRODUCTS, INC. · Class I
- Galabins méhszonda, d= 3, 6 mm, 295 mm — SUBAN Kéziműszer Hungary Zártkörűen Működő Részvénytársaság · Class I
- Surgical Direct — SURGICAL DIRECT, INC. · Class I
- V. Mueller — STERIS CORPORATION · Class I
- AESCULAP — AESCULAP, INC. · Class I
- Martin méhszonda, d= 3 mm, 300 mm — SUBAN Kéziműszer Hungary Zártkörűen Működő Részvénytársaság · 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 |
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Manufacturer
- Manufacturer
- AVALIGN TECHNOLOGIES, Inc.
Sources (1)
- FDA UDI 4c88d2e7-22a5-46a2-896c-4e1d65be3465 34 fields · synced May 30, 2026