Primary Device ID | 20627825000028 |
NIH Device Record Key | a3ae2410-82ab-41e9-8bb7-569dbb0ba6a7 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | injeTAK Adjustable Tip Needle 70cm |
Version Model Number | DIS201 |
Company DUNS | 203383526 |
Company Name | Laborie Medical Technologies Canada ULC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
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 | 00627825000024 [Primary] |
GS1 | 10627825000021 [Package] Contains: 00627825000024 Package: [2 Units] In Commercial Distribution |
GS1 | 20627825000028 [Package] Contains: 10627825000021 Package: [50 Units] In Commercial Distribution |
FBK | endoscopic injection needle, gastroenterology-urology |
Steralize Prior To Use | true |
Device Is Sterile | true |
[20627825000028]
Ethylene Oxide
[20627825000028]
Ethylene Oxide
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-09-21 |
30627825007024 - Extension Set 2 | 2022-07-04 |
20627825007294 - Extension Line, 60 cm | 2022-07-04 |
20627825007317 - Extension Line, 1500mm | 2022-07-04 |
20627825007324 - Extension Line, 15cm | 2022-07-04 |
20627825007348 - Extension Line, 150cm Blue | 2022-07-04 |
30627825007352 - Extension Line, 150cm Yellow | 2022-07-04 |
20627825007034 - Extension Set 3 | 2022-07-04 |
30627825007307 - Extension Line, 90 cm | 2022-07-04 |