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Catheter, Pabd, Single Lumen, Split Balloon, PVC , Introducer 4.5Fr

FDA UDI

Class II (US FDA UDI)

by Laborie Medical Technologies Canada ULC

Identity

Trade Name
Catheter, Pabd, Single Lumen, Split Balloon, PVC , Introducer 4.5Fr FDA UDI
Generic Name
Urodynamic manometric catheter, non-electronic FDA UDI
Model / Reference
CATW1A15ESI FDA UDI

Identifiers

Primary DI / UDI-DI
10627825010488 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

Yes

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: Urodynamic manometric catheter, non-electronic

Catheter, Pabd, Single Lumen, Split Balloon, PVC , Introducer 4.5Fr by Laborie Medical Technologies Canada ULC — Class II — FDA UDI — listed in FDA GUDID

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 a6be5260-cfed-4aa3-a94d-1d3462ab2b6e 32 fields · synced Jun 8, 2026