FDA UDI
In Commercial Distribution
🇺🇸 United States
MARK3
DI: D79661151
·
Model: 6115
·
CARGUS INTERNATIONAL, INC
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
200
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Basic Information
- Brand Name
- MARK3
- Primary DI
- D79661151
- Version / Model
- 6115
- Company Name
- CARGUS INTERNATIONAL, INC
- Labeler DUNS
- 096191093
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 200
- Record Status
- Published
- Publish Date
- 2021-07-16
- Public Version
- 2
- Public Version Date
- 2023-08-30
- Public Version Status
- Update
- Public Device Record Key
- a78cc87c-e426-4eca-abbc-ce16269cd742
Device Description
Self Seal 3-1/4" x 12"(3-1/4" x 11") Sterilization Pouches 200/bx. Case 10/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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JOJ | Indicator, Physical/Chemical Sterilization Process | General Hospital | 880.2800 | 2 |
| FRG | Wrap, Sterilization | General Hospital | 880.6850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60908 | Sterilization container liner | A non-sterile device intended to be used to line containers used for steam or solvent sterilization (e.g., trays, wraps, pouches) to absorb moisture and protect the container's finish. It is typically made of an absorbent, non-woven material or paper. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | D7966115 | HIBCC | ||||
| Primary | D79661151 | HIBCC | ||||
| Package | D79661152 | HIBCC | Box | 10 | In Commercial Distribution |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in cool, dry place.