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Rectal Split Balloon Catheter

FDA UDI

Class II (US FDA UDI)

by Laborie Medical Technologies Canada ULC

Identity

Trade Name
Rectal Split Balloon Catheter FDA UDI
Generic Name
Urodynamic manometric catheter, non-electronic FDA UDI
Device Name
4.5F FDA UDI
Model / Reference
9021P4460 FDA UDI
Description
4.5F FDA UDI

Identifiers

Primary DI / UDI-DI
00627825006996 FDA UDI
FDA Product Code
FEN FDA UDI
GMDN Term
Urodynamic manometric catheter, non-electronic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1620 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Urodynamic manometric catheter, non-electronic

Rectal Split Balloon Catheter by Laborie Medical Technologies Canada ULC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Urodynamic manometric catheter, non-electronic.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Laborie Medical Technologies Canada ULC

Sources (1)

  • FDA UDI 920c8e7d-99d9-4967-b399-12e1be5b33e1 33 fields · synced Jun 1, 2026