FDA UDI
In Commercial Distribution
🇺🇸 United States
MARK3
DI: D7961330LA0
·
Model: 1330LA
·
CARGUS INTERNATIONAL, INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MARK3
- Primary DI
- D7961330LA0
- Version / Model
- 1330LA
- Company Name
- CARGUS INTERNATIONAL, INC
- Labeler DUNS
- 096191093
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-27
- Public Version
- 2
- Public Version Date
- 2023-10-18
- Public Version Status
- Update
- Public Device Record Key
- e74356be-41dc-46d1-937f-2b866697f4e1
Device Description
Tray Covers Lavender Ritter B 8-1/2" x 12-1/4" 1,000/cs. - MARK3
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NRD | Unit, Operative Dental, Accessories | Dental | 872.6640 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63780 | Laboratory instrument/analyser absorbent liner IVD | A non-sterile sheet or pad made from natural materials (e.g., cotton, paper) intended to be used to absorb spilt liquids onboard a liquid-handling laboratory analyser or instrument. It is intended to create a barrier to contamination, help reduce cleaning requirements, and protect the analyser/instrument from damage (e.g., corrosion). The device is typically placed inside a tray, bin, or other specific area of the analyser/instrument where liquids are likely to spill or splash during in vitro diagnostic procedures. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D7961330LA0 | HIBCC |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in cool, dry place.