| Primary Device ID | 00191072232014 |
| NIH Device Record Key | af52817c-57ad-4386-8d33-20f10824c97d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ACS |
| Version Model Number | SAGL57L |
| 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 | 00191072232014 [Primary] |
| FDE | laparoscopy kit |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00191072232014]
Ethylene Oxide
[00191072232014]
Ethylene Oxide
[00191072232014]
Ethylene Oxide
[00191072232014]
Ethylene Oxide
[00191072232014]
Ethylene Oxide
[00191072232014]
Ethylene Oxide
[00191072232014]
Ethylene Oxide
[00191072232014]
Ethylene Oxide
[00191072232014]
Ethylene Oxide
[00191072232014]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-02 |
| Device Publish Date | 2024-11-24 |
| 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 |