SealPTFE™ S7005S

GUDID 05037881002781

SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall

VASCUTEK LTD

Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft
Primary Device ID05037881002781
NIH Device Record Keyb2643d18-ec85-4b7e-bede-87bda0f981b4
Commercial Distribution StatusIn Commercial Distribution
Brand NameSealPTFE™
Version Model NumberS7005S
Catalog NumberS7005S
Company DUNS229053087
Company NameVASCUTEK LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)888-3786
Emailtmccustomer.admin@terumomedical.com

Device Dimensions

Length70 Centimeter
Length70 Centimeter
Lumen/Inner Diameter5 Millimeter
Length70 Centimeter
Lumen/Inner Diameter5 Millimeter
Length70 Centimeter
Lumen/Inner Diameter5 Millimeter
Length70 Centimeter
Lumen/Inner Diameter5 Millimeter
Length70 Centimeter
Lumen/Inner Diameter5 Millimeter
Length70 Centimeter
Lumen/Inner Diameter5 Millimeter
Length70 Centimeter
Lumen/Inner Diameter5 Millimeter
Length70 Centimeter
Lumen/Inner Diameter5 Millimeter
Length70 Centimeter
Lumen/Inner Diameter5 Millimeter
Length70 Centimeter
Lumen/Inner Diameter5 Millimeter
Length70 Centimeter
Lumen/Inner Diameter5 Millimeter
Length70 Centimeter
Lumen/Inner Diameter5 Millimeter
Length70 Centimeter
Lumen/Inner Diameter5 Millimeter
Length70 Centimeter
Lumen/Inner Diameter5 Millimeter
Length70 Centimeter
Lumen/Inner Diameter5 Millimeter
Length70 Centimeter
Lumen/Inner Diameter5 Millimeter
Length70 Centimeter
Lumen/Inner Diameter5 Millimeter
Length70 Centimeter
Lumen/Inner Diameter5 Millimeter
Length70 Centimeter
Lumen/Inner Diameter5 Millimeter
Length70 Centimeter
Lumen/Inner Diameter5 Millimeter
Length70 Centimeter
Lumen/Inner Diameter5 Millimeter
Length70 Centimeter
Lumen/Inner Diameter5 Millimeter
Length70 Centimeter
Lumen/Inner Diameter5 Millimeter
Length70 Centimeter
Lumen/Inner Diameter5 Millimeter
Length70 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.

Device Identifiers

Device Issuing AgencyDevice ID
GS105037881002781 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DSYPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
MALGRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-03-25
Device Publish Date2015-10-19

On-Brand Devices [SealPTFE™]

05037881999173SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Thin Wall Straight with Central Support
05037881153292SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC
05037881153285SEALPTFE Wrap with Unity Construction Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall St
05037881153278SEALPTFE Wrap with Unity Construction Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall St
05037881153261SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC
05037881153247SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC
05037881153230SEALPTFE Wrap with Unity Construction Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall St
05037881153223SEALPTFE Wrap with Unity Construction Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall St
05037881153216SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC
05037881153193SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC
05037881153186SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC
05037881153179SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC
05037881153162SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC
05037881153148SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC
05037881153131SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC
05037881153124SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC
05037881153117SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC
05037881153094SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC
05037881153087SEALPTFE Wrap with Unity Construction Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall St
05037881153070SEALPTFE Wrap with Unity Construction Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall St
05037881153063SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC
05037881153056SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC
05037881153032SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC
05037881153025SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC
05037881153018SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC
05037881152981SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC
05037881152974SEALPTFE Wrap with Unity Construction Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall St
05037881152967SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC
05037881152943SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC
05037881152936SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC
05037881152929SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC
05037881152899SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED
05037881152882SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED
05037881152875SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED
05037881152868SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED
05037881152844SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED
05037881152837SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED
05037881152820SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED
05037881152813SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED
05037881152806SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED
05037881152790SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED
05037881152783SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED
05037881152776SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED
05037881152769SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED
05037881152752SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED
05037881152745SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED
05037881152738SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED
05037881152721SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED
05037881152714SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED
05037881152691SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED

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