Primary Device ID | 16975085709111 |
NIH Device Record Key | 9bf004de-f4a3-4fc7-a522-e81fa051f892 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Artromed |
Version Model Number | AM3004 |
Catalog Number | AM3004 |
Company DUNS | 014464314 |
Company Name | EXACT MEDICAL MANUFACTURING, INC. |
Device Count | 1 |
DM Exempt | true |
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 | false |
OTC Over-The-Counter | true |
Device Issuing Agency | Device ID |
---|---|
GS1 | 06975085709114 [Primary] |
GS1 | 16975085709111 [Package] Contains: 06975085709114 Package: Case [50 Units] In Commercial Distribution |
GS1 | 26975085709118 [Package] Package: Case [2 Units] In Commercial Distribution |
KKX | Drape, Surgical |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-04-11 |
Device Publish Date | 2023-04-03 |
16975085709111 | Camera Drape, Blue Elasticized Tip 18x244cm |
16975085709104 | CAK XI, C1 Clip Drape 86", 2 band 36x36", FSC |
16975085709425 | Camera Drape, Closed System Coupler & Ring Applicator, 6"x98" |