FDA UDI
In Commercial Distribution
🇺🇸 United States
VasQ DMST
DI: 07290016063387
·
Model: 20 Unit pack
·
LAMINATE MEDICAL TECHNOLOGIES LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Basic Information
- Brand Name
- VasQ DMST
- Primary DI
- 07290016063387
- Version / Model
- 20 Unit pack
- Catalog Number
- FG0038
- Company Name
- LAMINATE MEDICAL TECHNOLOGIES LTD
- Labeler DUNS
- 600196773
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2023-11-26
- Public Version
- 1
- Public Version Date
- 2023-12-04
- Public Version Status
- New
- Public Device Record Key
- 3ea73937-af84-4d65-9e40-317dc1e37f67
Device Description
Disposable Model Selection Tool for VasQ
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| FTY | Tape, Measuring, Rulers And Calipers | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44744 | Open-surgery blood vessel sizer, single-use | A sterile, invasive instrument intended to be used during open vascular surgery to approximate the size of a blood vessel for selection of an appropriately sized vascular device/implant (e.g., vascular graft, emboli filter); it is not intended to obtain a precise measurement. The device typically consists of a C-shaped (half circle) sizing portion with a handle, sometimes available in a range of sizes, and is intended to size the outer diameter of the blood vessel (i.e., extraluminal sizing); it may in addition be used to size a vascular graft. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290016063387 | GS1 | ||||
| Unit of Use | 07290016063011 | GS1 |