FDA UDI
In Commercial Distribution
🇺🇸 United States
MARK3
DI: D79621021
·
Model: 2102
·
CARGUS INTERNATIONAL, INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MARK3
- Primary DI
- D79621021
- Version / Model
- 2102
- Company Name
- CARGUS INTERNATIONAL, INC
- Labeler DUNS
- 096191093
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-29
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 10231a61-c1e4-4a8a-8142-27663dd00500
Device Description
Barrier Film Clear 4" x 6" Roll of 1,200 Sheets Per Box - MARK3
Device Characteristics
- Single Use
- No
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| PEM | Dental Barriers And Sleeves | General, Plastic Surgery | 878.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61050 | Dental bib | A non-sterile device intended to be worn by a patient during a dental examination or treatment procedure to function as a barrier to soiling and cross-contamination. It typically consists of a shaped piece of natural and/or synthetic material intended to be fastened around the neck and cover the front side of the upper body. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D79621021 | HIBCC |