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8 Ch. Single Use Anorectal Manometry Catheter-Radi

FDA UDI

Class II (US FDA UDI)

by Laborie Medical Technologies Canada ULC

Identity

Trade Name
8 Ch. Single Use Anorectal Manometry Catheter-Radi FDA UDI
Generic Name
Urodynamic manometric catheter, non-electronic FDA UDI
Model / Reference
9012P1312 FDA UDI

Identifiers

Primary DI / UDI-DI
10627825008287 FDA UDI
510(k) Number
K963064 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: Urodynamic manometric catheter, non-electronic

8 Ch. Single Use Anorectal Manometry Catheter-Radi by Laborie Medical Technologies Canada ULC — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Urodynamic manometric catheter, non-electronic.

Cleared under the same submission

K963064 also covers:

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 2753c065-bc02-4c49-b6a7-7c58f28801b7 33 fields · synced Jun 8, 2026