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Ambler Surgical

FDA UDI

Class I (US FDA UDI)

by Ambler Surgical, LLC

Identity

Trade Name
Ambler Surgical FDA UDI
Generic Name
Suprapubic catheter introducer, reusable FDA UDI
Device Name
Ochsner gallbladder trocar, 6'', 14 French, for 10 French catheter FDA UDI
Model / Reference
Ochsner gallbladder trocar FDA UDI
Description
Ochsner gallbladder trocar, 6'', 14 French, for 10 French catheter FDA UDI

Identifiers

Catalog Number
195-314 FDA UDI
Primary DI / UDI-DI
00190660218263 FDA UDI
FDA Product Code
MDM FDA UDI
GMDN Term
Suprapubic catheter introducer, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Suprapubic catheter introducer, reusable

Ambler Surgical by Ambler Surgical, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Suprapubic catheter introducer, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ambler Surgical, LLC

Sources (1)

  • FDA UDI 1570a26b-84a3-4047-9d1b-a01a2e77f784 35 fields · synced May 30, 2026