FDA UDI
In Commercial Distribution
🇺🇸 United States
MYNX CONTROL™ VENOUS Vascular Closure Device 6F-12F
DI: 10705032090278
·
Model: MX61260
·
Cordis US Corp.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MYNX CONTROL™ VENOUS Vascular Closure Device 6F-12F
- Primary DI
- 10705032090278
- Version / Model
- MX61260
- Catalog Number
- MX61260
- Company Name
- Cordis US Corp.
- Labeler DUNS
- 118274128
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-05
- Public Version
- 1
- Public Version Date
- 2024-07-15
- Public Version Status
- New
- Public Device Record Key
- d539f278-cda5-4845-95c8-cd142b4dc737
Device Description
MYNX CONTROL™ VENOUS Vascular Closure Device 6F-12F
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MGB | Device, Hemostasis, Vascular | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47764 | Wound hydrogel dressing, non-antimicrobial | A wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases; it does not include an antimicrobial agent(s). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20705032090275 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 10705032090278 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P040044 | 097 |