Primary Device ID | 10627825007334 |
NIH Device Record Key | 22517bc6-cfa9-4b0b-97a1-df5f4e60c9cc |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Cystometry Pack |
Version Model Number | 9021T1031 |
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 | 00627825007320 [Primary] |
GS1 | 10627825007334 [Package] Contains: 00627825007320 Package: [10 Units] In Commercial Distribution |
FEN | DEVICE, CYSTOMETRIC, HYDRAULIC |
Steralize Prior To Use | true |
Device Is Sterile | true |
[10627825007334]
Ethylene Oxide
[10627825007334]
Ethylene Oxide
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2016-09-21 |
10627825007488 | with Rectal Split Balloon with Introducer, 10F |
10627825007426 | with Rectal Flap, 6F |
10627825007396 | with Rectal Split Balloon with Introducer, 6F |
10627825008515 | with Rectal Split Balloon, 6F |
10627825007334 | with Rectal Flap, 8F |
10627825007303 | with Rectal Split balloon with Introducer, 8F |
10627825007273 | with Rectal Split balloon, 8F |