Primary Device ID | 10817984010065 |
NIH Device Record Key | 2e5f96c4-39b6-4db6-b0ca-49dc635d719b |
Commercial Distribution Discontinuation | 2020-01-10 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | Laser Lavage |
Version Model Number | 0600-3012-000 |
Catalog Number | 0600-3012-000 |
Company DUNS | 606939072 |
Company Name | MECTRA LABS, INC. |
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 | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(800)323-3968 |
mectrasales@mectralabs.com | |
Phone | +1(800)323-3968 |
mectrasales@mectralabs.com |
Handling Environment Temperature | Between 20 Degrees Fahrenheit and 115 Degrees Fahrenheit |
Handling Environment Temperature | Between 20 Degrees Fahrenheit and 115 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00817984010068 [Primary] |
GS1 | 10817984010065 [Package] Contains: 00817984010068 Package: Inner pack [10 Units] Discontinued: 2020-01-10 Not in Commercial Distribution |
GBX | CATHETER, IRRIGATION |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2020-01-13 |
Device Publish Date | 2019-01-25 |
10817984010072 | Laser Lavage Double Bottle |
10817984010065 | Laser Lavage Dual Spike |
10817984010058 | Laser Lavage Single Spike |
10817984010362 | Laser Lavage 32CM Single Spike |