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Exair

FDA UDI

Class III (US FDA UDI)

by Coloplast A/S

Identity

Trade Name
Exair FDA UDI
Generic Name
Suturing unit, single-use FDA UDI
Device Name
Prolapse Repair System - Posterior FDA UDI
Model / Reference
50150 FDA UDI
Description
Prolapse Repair System - Posterior FDA UDI

Identifiers

Catalog Number
50150 FDA UDI
Primary DI / UDI-DI
05708932459433 FDA UDI
FDA Product Code
OTP FDA UDI
GMDN Term
Suturing unit, single-use FDA UDI

Classification

Device Class
Class III FDA UDI
Regulation Number
884.5980 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Suturing unit, single-useFemale stress urinary incontinence surgical mesh-sling, synthetic polymer

Exair by Coloplast A/S — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Female stress urinary incontinence surgical mesh-sling, synthetic polymer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Coloplast A/S

Sources (1)

  • FDA UDI e2a090f6-893c-4965-b469-0fbb320ef26f 36 fields · synced May 30, 2026