MARK3
- Primary DI
- D79620001
- Brand
- MARK3
- Company
- CARGUS INTERNATIONAL, INC
- Model
- 2000
- Catalog number
- 2000
- Device description
- Cotton Rolls Non Sterile #2 2000/bx. - MARK3®*
- Published
- 2023-08-01
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- true
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| EFN | Cotton, Roll | Dental | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| D79620002 | Package | HIBCC | 12 | In Commercial Distribution |
| D79620001 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Woven gauze roll/sheet | A device in the form of a long length of stretchable, absorbent, woven material (e.g., cotton, cellulose), wound into a roll or folded, and typically designed for a variety of applications (non-dedicated) such as a primary wound dressing, dressing retention, and injury padding and compression. It is not a dedicated pressure dressing and does not include latex. This is a single-use device. |
Regulatory Flags
- DUNS number
- 096191093
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- 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
- false
Other Devices From This Company
Other Devices Sharing Product Codes
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|---|
| 00810194401794 | Aira | AIRA, LLC | EFN | 2026-01-16 |
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| 10810132808200 | House Brand Dentistry | Frontier Dental Supply Inc | EFN | 2025-08-05 |
| 00840456214947 | JMU | JMU DENTAL, INC | EFN | 2025-07-15 |
| 00840456214954 | JMU | JMU DENTAL, INC | EFN | 2025-07-15 |
| 00840456214961 | JMU | JMU DENTAL, INC | EFN | 2025-07-15 |
| 00840456214978 | JMU | JMU DENTAL, INC | EFN | 2025-07-15 |
| 20810132044285 | HCS Sourcing | Concordance Healthcare Solutions LLC | EFN | 2025-04-07 |
| 20810132044278 | HCS | Concordance Healthcare Solutions LLC | EFN | 2025-03-05 |
| D77810701992 | Scott's Select Cotton Rolls | SCOTT'S DENTAL SUPPLY L.L.C. | EFN | 2024-08-27 |
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| 00304040184813 | Henry Schein | HENRY SCHEIN, INC. | EFN | 2024-08-15 |
| 00304040184820 | Henry Schein | HENRY SCHEIN, INC. | EFN | 2024-08-15 |
| 00304040184851 | Henry Schein | HENRY SCHEIN, INC. | EFN | 2024-08-15 |
| 00304040184868 | Henry Schein | HENRY SCHEIN, INC. | EFN | 2024-08-15 |
| 00850053289538 | SURGYCO | Surgyco LLC | EFN | 2024-08-09 |
| 00850053289545 | SURGYCO | Surgyco LLC | EFN | 2024-08-09 |
| 00304040184837 | Henry Schein | HENRY SCHEIN, INC. | EFN | 2024-06-26 |
| 00304040184844 | Henry Schein | HENRY SCHEIN, INC. | EFN | 2024-06-26 |
| 00854014003270 | SAFE DENT | BGSS Company Inc. | EFN | 2024-05-01 |
| 00854014003300 | SAFE DENT | BGSS Company Inc. | EFN | 2024-05-01 |
| 00854014003348 | SAFE DENT | BGSS Company Inc. | EFN | 2024-05-01 |
| 00854014003379 | SAFE DENT | BGSS Company Inc. | EFN | 2024-05-01 |
| 20815878025321 | Burkhart Non-Woven Sponges | CROSSTEX INTERNATIONAL, INC. | EFN | 2024-04-09 |
| 20815878027585 | Burkhart Non-Woven Sponges | CROSSTEX INTERNATIONAL, INC. | EFN | 2024-04-09 |
| 20815878028483 | Burkhart Non-Woven Sponges | CROSSTEX INTERNATIONAL, INC. | EFN | 2024-04-09 |
| 00653078997552 | Avaline Medical NJ LLC | Avaline Medical NJ Limited Liability Company | EFN | 2023-12-15 |
| 00810124531225 | Avaline Medical NJ LLC | Avaline Medical NJ Limited Liability Company | EFN | 2023-12-15 |
| 00810124531218 | Avaline Medical NJ LLC | Avaline Medical NJ Limited Liability Company | EFN | 2023-12-15 |
| 06974669350353 | MDHC | MDHC Life Technologies (Kunshan) Co., LTD. | EFN | 2023-07-06 |
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