Primary Device ID | 00191072184023 |
NIH Device Record Key | 68eed5e9-bf35-4cd4-bbcc-e495f3302f58 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ACS |
Version Model Number | GBCS14D |
Company DUNS | 010334675 |
Company Name | AMERICAN CONTRACT SYSTEMS, INC. |
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 | true |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | true |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00191072184023 [Primary] |
OHM | Cesarean Section Tray |
OMH | Pericardial patch to facilitate revision surgeries |
Steralize Prior To Use | true |
Device Is Sterile | true |
[00191072184023]
Ethylene Oxide
[00191072184023]
Ethylene Oxide
[00191072184023]
Ethylene Oxide
[00191072184023]
Ethylene Oxide
[00191072184023]
Ethylene Oxide
[00191072184023]
Ethylene Oxide
[00191072184023]
Ethylene Oxide
[00191072184023]
Ethylene Oxide
[00191072184023]
Ethylene Oxide
[00191072184023]
Ethylene Oxide
[00191072184023]
Ethylene Oxide
[00191072184023]
Ethylene Oxide
[00191072184023]
Ethylene Oxide
[00191072184023]
Ethylene Oxide
[00191072184023]
Ethylene Oxide
[00191072184023]
Ethylene Oxide
[00191072184023]
Ethylene Oxide
[00191072184023]
Ethylene Oxide
[00191072184023]
Ethylene Oxide
[00191072184023]
Ethylene Oxide
[00191072184023]
Ethylene Oxide
[00191072184023]
Ethylene Oxide
[00191072184023]
Ethylene Oxide
[00191072184023]
Ethylene Oxide
[00191072184023]
Ethylene Oxide
[00191072184023]
Ethylene Oxide
[00191072184023]
Ethylene Oxide
[00191072184023]
Ethylene Oxide
[00191072184023]
Ethylene Oxide
[00191072184023]
Ethylene Oxide
[00191072184023]
Ethylene Oxide
[00191072184023]
Ethylene Oxide
[00191072184023]
Ethylene Oxide
[00191072184023]
Ethylene Oxide
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-07-24 |
Device Publish Date | 2023-07-14 |
00191072000057 | OUTPATIENT PORT ACCESS KIT |
00191072000040 | LABOR DELIVERY PACK - 213387 |
00191072000033 | C-SECTION PACK 2 - 242901 |
00191072000026 | C-SECTION PACK - 205965 |
00191072000019 | CLEAN CLOSURE PACK - 289126 |
00191072000002 | STANDARD ARTHROSCOPY PACK - 291852 |
00191072000071 | LEVEL 1 PPE KIT (REV 3)NONSTERILE-277567 |
00191072000064 | LEVEL 2A PPE KIT(REV 4)NONSTERILE-288133 |
00191072033383 | T&A PACK |
00191072032652 | PROMEDICA BARRIER KIT |
00191072032478 | CNRV PERIPHERAL VAS |
00191072032447 | CNRV MAJ LITH/LAVH ACC |
00191072032416 | CNRV LITHOTOMY |
00191072032348 | CNRV GYN LAP |
00191072032324 | CNRV CAROTID ACCESS |
00191072031983 | GU-GYN-LITHO PACK |
00191072031921 | CV PACK |
00191072031419 | PEDS HEART DONOR PACK |
00191072031075 | ADULT HEART DONOR PACK |
00191072030986 | ER PELVIC KIT |
00191072030948 | D & C PACK |
00191072030634 | KNEE ARTHROSCOPY |
00191072030573 | TOTAL KNEE |
00191072030566 | SHOULDER PACK |
00191072030535 | LAP CHOLE PACK |
00191072030221 | BARRIER PACK |
00191072030153 | OPEN HEART A PACK |
00191072030054 | CDC COMPLIANCE KIT |
00191072029560 | CMC POSTERIOR HIP PACK |
00191072029546 | VALVE REPLACEMENT |
00191072029348 | CMC TOTAL KNEE |
00191072029324 | ANTERIOR HIP PACK |
00191072029287 | CMC LABOR AND DELIVERY |
00191072029126 | CORONARY BYPASS |
00191072029072 | BREAST PROCEDURE |
00191072028075 | BIOPSY TRAY |
00191072027672 | T & A PACK VARNER PACL |
00191072027658 | RADIOLOGY DRAPE PACK |
00191072027597 | MAJOR LITHOTOMY PACK |
00191072027573 | KYPHOPLASTY PACK |
00191072026927 | ACDF |
00191072025586 | HEART CABG |
00191072024800 | TONSILS AND ADNOIDS |
00191072024251 | VASCULAR PACK |
00191072024206 | PAIN PACK |
00191072024190 | OB GYN LAPAROSCOPIC TRAY |
00191072024169 | HYSTEROSCOPY PACK |
00191072024039 | RADIOLOGY ARTERIOGRAM PACK |
00191072023964 | LAVH |
00191072023933 | CUSTOM HEART PACK II |