Identity
- Trade Name
- Ambler Surgical FDA UDI
- Generic Name
- Aorta punch, reusable FDA UDI
- Device Name
- Bailey aortic rongeur, working length 135mm, straight jaws, 3.0mm bite, ring handle FDA UDI
- Model / Reference
- Bailey aortic rongeur FDA UDI
- Description
- Bailey aortic rongeur, working length 135mm, straight jaws, 3.0mm bite, ring handle FDA UDI
Identifiers
- Catalog Number
- 75-140 FDA UDI
- Primary DI / UDI-DI
- 00190660144913 FDA UDI
- FDA Product Code
- DWS FDA UDI
- GMDN Term
- Aorta punch, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 870.4500 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: Aorta punch, reusable
Ambler Surgical by Ambler Surgical, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Aorta punch, reusable.
- AESCULAP — AESCULAP, INC. · Class I
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- VASCUCUT — AESCULAP, INC. · Class I
- SONTEC AORTIC PUNCH — SONTEC INSTRUMENTS, INC. · Class I
- Wexler Surgical, Inc. — Wexler Surgical, Inc. · Class I
- VASCUCUT — AESCULAP, INC. · Class I
- BOSS Instruments — Boss Instruments, Ltd. · Class I
- Wexler Surgical, Inc. — Wexler Surgical, 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 88365179-3a6c-49cb-90ef-02bfab160ade 35 fields · synced May 31, 2026