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Surgipros

FDA UDI

Class I (US FDA UDI)

by Surgipros Llc

Identity

Trade Name
SURGIPROS FDA UDI
Generic Name
Filiform urethral bougie FDA UDI
Device Name
MANDRIN INSERTION CATHETER FDA UDI
Model / Reference
27618SP FDA UDI
Description
MANDRIN INSERTION CATHETER FDA UDI

Identifiers

Primary DI / UDI-DI
00810143901191 FDA UDI
FDA Product Code
EZB FDA UDI
GMDN Term
Filiform urethral bougie FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
876.5130 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

No

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

No

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: Filiform urethral bougie

Surgipros by Surgipros Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Filiform urethral bougie.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Surgipros Llc

Sources (1)

  • FDA UDI 73335f69-5e6d-4715-a52f-a917c23e255a 34 fields · synced May 30, 2026