ACS
- Primary DI
- 00191072149299
- Brand
- ACS
- Company
- AMERICAN CONTRACT SYSTEMS, INC.
- Model
- CXBB12D
- Device description
- BREAST BIOPSY
- Published
- 2021-10-14
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- true
- Single use
- true
Related Records
Product Codes
| Code | Name |
|---|---|
| FCH | TRAY, BIOPSY, WITHOUT BIOPSY INSTRUMENTS |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| FCH | Tray, Biopsy, Without Biopsy Instruments | Gastroenterology, Urology | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00191072149299 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00191072149299 | 00191072149299 | 191072149299 | 0191072149299 |
GMDN Terms
| Term | Definition |
|---|---|
| General/plastic surgical procedure kit, non-medicated, single-use | A collection of various surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device. |
Sterilization Methods
| Method |
|---|
| Ethylene Oxide |
Regulatory Flags
- DUNS number
- 010334675
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- true
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00191072241948 | ACS | AMMV04AE | 2026-03-24 | |
| 00191072241962 | ACS | FDCR00AE | 2026-03-24 | |
| 00191072241979 | ACS | LKTK16AB | 2026-03-24 | |
| 00191072241986 | ACS | LKTH15W | 2026-03-24 | |
| 00191072241993 | ACS | FDTH08AJ | 2026-03-24 | |
| 00191072242006 | ACS | FDTK07AH | 2026-03-24 | |
| 00191072242013 | ACS | FDKA44S | 2026-03-24 | |
| 00191072242020 | ACS | FDSA15N | 2026-03-24 | |
| 00191072242037 | ACS | BPHA89E | 2026-03-24 | |
| 00191072241757 | ACS | SPSA58S | 2026-02-19 | |
| 00191072241764 | ACS | LLGT12F | 2026-02-19 | |
| 00191072241801 | ACS | CIEY01G | 2026-02-19 | |
| 00191072241818 | ACS | WEHF12B | 2026-02-19 | |
| 00191072241856 | ACS | RGLC12P | 2026-02-19 | |
| 00191072241863 | ACS | UIHN18AZ | 2026-02-19 | |
| 00191072241870 | ACS | BDAG39C | 2026-02-19 | |
| 00191072241887 | ACS | IHTK48AO | 2026-02-19 | |
| 00191072241894 | ACS | IHTR90N | 2026-02-19 | |
| 00191072241900 | ACS | UICA66AS | 2026-02-19 | |
| 00191072241917 | ACS | MWTK13AI | 2026-02-19 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| M78312011161 | Diversatek Healthcare | DIVERSATEK HEALTHCARE, INC. | FCH | 2025-11-14 |
| 00810185250370 | Therapak | Therapak LLC | FCH | 2025-08-11 |
| 00810185250431 | Therapak | Therapak LLC | FCH | 2025-08-11 |
| 00810185250455 | Therapak | Therapak LLC | FCH | 2025-08-11 |
| 00810185250530 | Therapak | Therapak LLC | FCH | 2025-08-11 |
| 00810185250394 | Therapak | Therapak LLC | FCH | 2025-08-04 |
| 20809160472030 | Halyard | AVID MEDICAL, INC. | FCH | 2025-07-02 |
| 00191072236067 | ACS | AMERICAN CONTRACT SYSTEMS, INC. | FCH | 2025-01-31 |
| 00191072236098 | ACS | AMERICAN CONTRACT SYSTEMS, INC. | FCH | 2025-01-31 |
| 00191072233714 | ACS | AMERICAN CONTRACT SYSTEMS, INC. | FCH | 2024-12-19 |
| M78312011101 | Diversatek Healthcare | DIVERSATEK HEALTHCARE, INC. | FCH | 2024-10-31 |
| 00191072231376 | ACS | AMERICAN CONTRACT SYSTEMS, INC. | FCH | 2024-10-21 |
| 00191072230935 | ACS | AMERICAN CONTRACT SYSTEMS, INC. | FCH | 2024-10-14 |
| M78312011081 | Diversatek Healthcare | DIVERSATEK HEALTHCARE, INC. | FCH | 2024-06-07 |
| 00191072223982 | ACS | AMERICAN CONTRACT SYSTEMS, INC. | FCH | 2024-05-08 |
| 00191072223999 | ACS | AMERICAN CONTRACT SYSTEMS, INC. | FCH | 2024-05-08 |
| 00191072223616 | ACS | AMERICAN CONTRACT SYSTEMS, INC. | FCH | 2024-05-03 |
| 00191072223111 | ACS | AMERICAN CONTRACT SYSTEMS, INC. | FCH | 2024-04-26 |
| 00191072222145 | ACS | AMERICAN CONTRACT SYSTEMS, INC. | FCH | 2024-04-15 |
| 00191072219077 | ACS | AMERICAN CONTRACT SYSTEMS, INC. | FCH | 2024-03-04 |
| 00191072219534 | ACS | AMERICAN CONTRACT SYSTEMS, INC. | FCH | 2024-03-04 |
| 00191072219855 | ACS | AMERICAN CONTRACT SYSTEMS, INC. | FCH | 2024-03-04 |
| M78312011061 | Diversatek Healthcare | DIVERSATEK HEALTHCARE, INC. | FCH | 2024-01-31 |
| 00191072213655 | ACS | AMERICAN CONTRACT SYSTEMS, INC. | FCH | 2023-12-19 |
| 00191072212993 | ACS | AMERICAN CONTRACT SYSTEMS, INC. | FCH | 2023-12-12 |
| 10849233013770 | Busse Hospital Disposables | ROBERT BUSSE & CO., INC. | FCH | 2023-12-12 |
| 00191072208316 | ACS | AMERICAN CONTRACT SYSTEMS, INC. | FCH | 2023-10-12 |
| 00191072206077 | ACS | AMERICAN CONTRACT SYSTEMS, INC. | FCH | 2023-09-27 |
| 00191072206114 | ACS | AMERICAN CONTRACT SYSTEMS, INC. | FCH | 2023-09-27 |
| 00191072202246 | ACS | AMERICAN CONTRACT SYSTEMS, INC. | FCH | 2023-08-28 |