DEVICE: Gelweave™ (05037881020822)

Download: XML | JSON

Device Identifier (DI) Information

Gelweave™
732812810/10STD
732812810/10STD
VASCUTEK LTD
05037881020822
GS1
1
Gelweave Gelatin Impregnated Woven Vascular Prosthesis ANATOMICAL PRECURVED 4 BRANCH PLEXUS
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Synthetic vascular graft A sterile 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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
DSY PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Store in a clean dry area. Prosthesis must be implanted within one month after removal from the foil pouch.
Handling Environment Temperature: between 0 and 35 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Lumen/Inner Diameter: 28 Millimeter
Length: 50 Centimeter
Device Size Text, specify: Branch length 15/15/15/15 cm
Device Size Text, specify: Branch diameter 12/8//10/10 mm
CLOSE

Device Status

In Commercial Distribution
October 19, 2015

CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
Yes
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)262-3304
xx@xx.xx
CLOSE