Primary Device ID | 00842071131180 |
NIH Device Record Key | 654b1329-6f6f-4e75-86d5-df1952c4d29b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ATLAS Suture Delivery System |
Version Model Number | ESD121-05-1 |
Catalog Number | ESD121-05-1, SD121-05-101, SD121-05-105 |
Company DUNS | 038101861 |
Company Name | APPLIED MEDICAL TECHNOLOGY, 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 | (440)717-4000 |
cs@appliedmedical.net | |
Phone | (440)717-4000 |
cs@appliedmedical.net | |
Phone | (440)717-4000 |
cs@appliedmedical.net | |
Phone | (440)717-4000 |
cs@appliedmedical.net | |
Phone | (440)717-4000 |
cs@appliedmedical.net | |
Phone | (440)717-4000 |
cs@appliedmedical.net | |
Phone | (440)717-4000 |
cs@appliedmedical.net | |
Phone | (440)717-4000 |
cs@appliedmedical.net | |
Phone | (440)717-4000 |
cs@appliedmedical.net | |
Phone | (440)717-4000 |
cs@appliedmedical.net | |
Phone | (440)717-4000 |
cs@appliedmedical.net | |
Phone | (440)717-4000 |
cs@appliedmedical.net | |
Phone | (440)717-4000 |
cs@appliedmedical.net | |
Phone | (440)717-4000 |
cs@appliedmedical.net | |
Phone | (440)717-4000 |
cs@appliedmedical.net | |
Phone | (440)717-4000 |
cs@appliedmedical.net |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00842071131128 [Primary] |
GS1 | 00842071131180 [Package] Contains: 00842071131128 Package: Box (SD121-05-101) [1 Units] In Commercial Distribution |
GS1 | 00842071131197 [Package] Contains: 00842071131128 Package: Box (SD121-05-105) [5 Units] In Commercial Distribution |
KGC | Tube, Gastro-Enterostomy |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-11-23 |
Device Publish Date | 2021-11-15 |
00842071131203 | ATLAS Suture Delivery System, 2-Pack (Pouched) |
00842071131180 | ATLAS Suture Delivery System, 1-Pack (Pouched) |