Diversatek Healthcare
- Primary DI
- M78312011200
- Brand
- Diversatek Healthcare
- Company
- DIVERSATEK HEALTHCARE, INC.
- Model
- 1201-120
- Catalog number
- 1201-120
- Device description
- Basic Endoscopy Procedure Kit
- Published
- 2026-10-30
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes#
Code, Name table| Code | Name |
|---|
| FCH | Tray, Biopsy, Without Biopsy Instruments |
Product Code Classifications#
Code, Device, Specialty table| Code | Device | Specialty | Class |
|---|
| FCH | Tray, Biopsy, Without Biopsy Instruments | Gastroenterology, Urology | 1 |
Identifiers And Packaging#
Identifier, Type, Agency table| Identifier | Type | Agency | Package quantity | Status |
|---|
| M78312011201 | Package | HIBCC | 20 | In Commercial Distribution |
| M78312011200 | Primary | HIBCC | 0 | |
Regulatory Flags#
- DUNS number
- 030650113
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
Other Devices From This Company#
Other Devices Sharing Product Codes#
Primary DI, Brand, Company table| Primary DI | Brand | Company | Product code | Published |
|---|
| M78312011160 | Diversatek Healthcare | DIVERSATEK HEALTHCARE, INC. | FCH | 2025-11-14 |
| M78312011161 | Diversatek Healthcare | DIVERSATEK HEALTHCARE, INC. | FCH | 2025-11-14 |
| 00810185250363 | Therapak | Therapak LLC | FCH | 2025-08-11 |
| 00810185250387 | Therapak | Therapak LLC | FCH | 2025-08-11 |
| 00810185250424 | Therapak | Therapak LLC | FCH | 2025-08-11 |
| 00810185250448 | Therapak | Therapak LLC | FCH | 2025-08-11 |
| 00810185250523 | Therapak | Therapak LLC | FCH | 2025-08-11 |
| 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 |
| 00810185250400 | Therapak | Therapak LLC | FCH | 2025-08-04 |
| 00810185250394 | Therapak | Therapak LLC | FCH | 2025-08-04 |
| 10809160472033 | Halyard | AVID MEDICAL, INC. | FCH | 2025-07-02 |
| 20809160472030 | Halyard | AVID MEDICAL, INC. | FCH | 2025-07-02 |
| M78312011150 | Diversatek Healthcare | DIVERSATEK HEALTHCARE, INC. | FCH | 2025-06-30 |
| 00191072239426 | ACS | AMERICAN CONTRACT SYSTEMS, INC. | FCH | 2025-05-27 |
| M78312011130 | Diversatek Healthcare | DIVERSATEK HEALTHCARE, INC. | FCH | 2025-04-03 |
| M78312011120 | Diversatek Healthcare | DIVERSATEK HEALTHCARE, INC. | FCH | 2025-02-28 |
| 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 |
| M78312011100 | Diversatek Healthcare | DIVERSATEK HEALTHCARE, INC. | FCH | 2024-10-31 |
| 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 |
| M78312011080 | Diversatek Healthcare | DIVERSATEK HEALTHCARE, INC. | FCH | 2024-06-07 |
| 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 |
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