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Colpassist

FDA UDI

Class I (US FDA UDI)

by Boston Scientific

Identity

Trade Name
Colpassist FDA UDI
Generic Name
Pelvic organ prolapse surgical mesh, synthetic polymer FDA UDI
Device Name
Vaginal Positioning Device FDA UDI
Model / Reference
M0068318210 FDA UDI
Description
Vaginal Positioning Device FDA UDI

Identifiers

Primary DI / UDI-DI
08714729848097 FDA UDI
FDA Product Code
KOH FDA UDI
GMDN Term
Pelvic organ prolapse surgical mesh, synthetic polymer FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
884.4520 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Pelvic organ prolapse surgical mesh, synthetic polymer

Colpassist by Boston Scientific — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pelvic organ prolapse surgical mesh, synthetic polymer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Boston Scientific

Sources (1)

  • FDA UDI a692c043-673b-462a-92ab-66de12125528 33 fields · synced May 30, 2026