Identity
- Trade Name
- Ambler Surgical FDA UDI
- Generic Name
- Fixed-diameter cervical dilator, reusable FDA UDI
- Device Name
- Hegar uterine dilator, 8'', double-ended, set of 8 includes size 3.0mm/4.0mm to 17.0mm/18.0mm (44-816, 44-817, 44-818, 44-819, 44-820, 44-821, 44-822 and 44-823) FDA UDI
- Model / Reference
- Hegar uterine dilator FDA UDI
- Description
- Hegar uterine dilator, 8'', double-ended, set of 8 includes size 3.0mm/4.0mm to 17.0mm/18.0mm (44-816, 44-817, 44-818, 44-819, 44-820, 44-821, 44-822 and 44-823) FDA UDI
Identifiers
- Catalog Number
- 44-814 FDA UDI
- Primary DI / UDI-DI
- 00190660030780 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
Yes
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
Ambler Surgical by Ambler Surgical, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Fixed-diameter cervical dilator, reusable.
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- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
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- Surgical Direct — SURGICAL DIRECT, INC. · Class I
- V. Mueller — STERIS CORPORATION · Class I
- AESCULAP — AESCULAP, INC. · 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
- Ambler Surgical, LLC
Sources (1)
- FDA UDI 3cdc3d97-89e7-45d2-a795-db655dcf9a93 35 fields · synced May 29, 2026