Two Catheter Set 10F and 4F

GUDID 10627825000397

Urodynamic manometric catheter, non-electronic

Primary Device ID	10627825000397
NIH Device Record Key	0e93463b-cd93-4993-a7ce-98984db97cc9
Commercial Distribution Status	In Commercial Distribution
Brand Name	Two Catheter Set 10F and 4F
Version Model Number	FCBP-104
Company DUNS	203383526
Company Name	Laborie Medical Technologies Canada ULC
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	false
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00627825000390 [Primary]
GS1	10627825000397 [Package] Contains: 00627825000390 Package: [10 Units] In Commercial Distribution
GS1	20627825000394 [Package] Package: [140 Units] In Commercial Distribution

FEN	DEVICE, CYSTOMETRIC, HYDRAULIC

Steralize Prior To Use	true
Device Is Sterile	true

[10627825000397]

Ethylene Oxide

[10627825000397]

Ethylene Oxide