DEVICE: VP1200K™ (05037881020044)

Device Identifier (DI) Information

VP1200K™
260808
Not in Commercial Distribution
260808
VASCUTEK LTD
05037881020044
GS1
November 20, 2018
1
229053087 *Terms of Use
VP1200K AX-BIFEM LEFT
CLOSE

Device Characteristics

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

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
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.
Active true
CLOSE

FDA Product Code

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

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K034010 000
No 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
Handling Environment Temperature: between 0 and 50 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Length: 100 Centimeter
Lumen/Inner Diameter: 8 Millimeter
Device Size Text, specify: Branch length 60cm
Device Size Text, specify: Branch diameter 8 mm
CLOSE

Device Record Status

a608db68-3516-40b0-ab52-a1584aeef6f5
February 05, 2021
5
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