DEVICE: Thoraflex™ Hybrid (05037881026718)

Download: XML | JSON
Print
Device Record History
View all sections | Close all sections

Device Identifier (DI) Information
Thoraflex™ Hybrid
THP2830X100A
In Commercial Distribution
THP2830X100A
VASCUTEK LTD
05037881026718
GS1

1
229053087 *Terms of Use
Thoraflex Hybrid Plexus 4 Hybrid Stent Device
CLOSE

Device Characteristics
MR Conditional
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. 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 a diseased or injured vessel, typically the aorta, an iliac, a femoral or popliteal artery; it is not intended for use in the coronary arteries. It is typically made of woven or knitted polyethylene terephthalate (Dacron) or polytetrafluoroethylene (PTFE) fabrics; it does not incorporate a metallic mesh (i.e., it is not a stent-graft).
Active true
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
QSK Hybrid stent graft, thoracic aortic lesion treatment
CLOSE

FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
P210006 000
P210006 001
P210006 002
P210006 003
P210006 004
P210006 005
P210006 006
P210006 007
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 cool dry place out of direct sunlight
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Branch Diameter 12,8,10,10
Length: 242100 Millimeter
Device Size Text, specify: Branch Length 150mm
Lumen/Inner Diameter: 28 Millimeter
CLOSE

Device Record Status
7c453606-f5a1-4931-90ea-fec5aba90ac5
September 24, 2025
4
May 31, 2022
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)

[?]
Yes
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE