DEVICE: SealPTFE™ (05037881152677)

Device Identifier (DI) Information

SealPTFE™
S4007PS
Not in Commercial Distribution
S4007PS
VASCUTEK LTD
05037881152677
GS1
March 30, 2019
1
229053087 *Terms of Use
SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED WITH A PTFE SUPPORT
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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
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FDA Product Code

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

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C).
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Clinically Relevant Size

[?]
Size Type Text
Length: 40 Centimeter
Lumen/Inner Diameter: 7 Millimeter
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Device Record Status

ad945924-196c-4435-93c8-0848bfb92188
February 05, 2021
7
October 19, 2015
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
Yes
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)888-3786
tmccustomer.admin@terumomedical.com
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