FDA UDI
In Commercial Distribution
🇺🇸 United States
Gelsoft™
DI: 05037881999463
·
Model: 631608/6RB
·
VASCUTEK LTD
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Gelsoft™
- Primary DI
- 05037881999463
- Version / Model
- 631608/6RB
- Catalog Number
- 631608/6RB
- Company Name
- VASCUTEK LTD
- Labeler DUNS
- 229053087
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-19
- Public Version
- 4
- Public Version Date
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- 095253fb-62b2-4ce9-8b1f-0e2116e23ab6
Device Description
Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis VS040 BIFURCATE WITH SINGLE SIDE BRANCH
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| DSY | PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER | Cardiovascular | 870.3450 | 2 |
| MAL | GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE | Cardiovascular | 870.3450 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35281 | Synthetic vascular graft | An implantable artificial substitute for a blood vessel intended to replace or bypass the diseased or injured vessel. It is typically made of woven or knitted polyethylene terephthalate (Dacron) or polytetrafluoroethylene (PTFE) fabrics and is best suited for large (more than 10 mm) diameter, high-flow vessel replacement (e.g., aortic or aorto-iliac artery reconstruction) and also for haemodialysis access and extra-anatomic bypass grafting. The device is used in many vascular bypass procedures (e.g., aorto-iliac, femoral-popliteal, axillo-axillary artery) except those involving the coronary arteries. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05037881999463 | GS1 |
Customer Contacts
- Phone
- +1(800)262-3304
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K990503 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Branch length 10 cm | ||
| Lumen/Inner Diameter | 18 | Millimeter | |
| Length | 45 | Centimeter | |
| Device Size Text, specify | Branch diameter 6/6 mm |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 35 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a clean dry area. Prosthesis must be implanted within one month after removal from the foil pouch.