AccessGUDID - DEVICE: Thoraflex™ Hybrid (05037881026732)

GUDID

Device Identifier (DI) Information

Brand Name: Thoraflex™ Hybrid
Version or Model: THP3034X100A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: THP3034X100A
Company Name: VASCUTEK LTD

Primary DI Number: 05037881026732
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 229053087 *Terms of Use

Device Description: Thoraflex Hybrid Plexus 4 Hybrid Stent Device

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

FDA Product Code

[?]

Product Code	Product Code Name
QSK	Hybrid stent graft, thoracic aortic lesion treatment

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store in a cool dry place out of direct sunlight

Clinically Relevant Size

[?]

Size Type Text
Length: 242100 Millimeter
Lumen/Inner Diameter: 30 Millimeter
Device Size Text, specify: Branch Length 150mm
Device Size Text, specify: Branch Diameter 12,8,10,10

Device Record Status

Public Device Record Key: 3dc40ca6-492b-433b-ad05-ffaedfeda788
Public Version Date: March 08, 2024
Public Version Number: 3
DI Record Publish Date: May 31, 2022

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

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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