FDA.report

Zenith

Primary DI
10827002124407
Brand
Zenith
Company
COOK INCORPORATED
Model
G12440
Catalog number
TFLE-10-54
Device description
Zenith, AAA Iliac Leg Graft
Published
2014-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Product Code Classifications

CodeDeviceSpecialtyClass
MIHSystem, Endovascular Graft, Aortic Aneurysm TreatmentUnknown3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10827002124407PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1082700212440710827002124407

GMDN Terms

TermDefinition
Synthetic vascular graftAn 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.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, dry, cool place.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(812)330-5494sharedservices@cookmedical.com

Regulatory Flags

DUNS number
042823948
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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10827002306735BakriG30673J-SOS-1005002016-09-24
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10827002496535Cotton-Leung Sof-FlexG49653CLSO-SF-10-52015-11-03
00827002352674HerculesG35267HBDE-W-8-9-102022-12-20
00827002352681HerculesG35268HBDE-W-10-11-122022-12-20
00827002352698HerculesG35269HBDE-W-12-13.5-152022-12-20
00827002352704HerculesG35270HBDE-W-15-16.5-182022-12-20
00827002352711HerculesG35271HBDE-W-18-19-202022-12-20
10827002346014FusionG34601FS-OMNI-ACRO-35-2052016-09-24
10827002346939FusionG34693FS-OMNI-ACRO-35-2602016-09-24
10827002347110FusionG34711FS-OMNI-ACRO-35-4502016-09-24
10827002347783D.A.S.H.G34778DASH-ACRO-35-4502016-09-24
10827002347790D.A.S.H.G34779DASH-ACRO-25-4502016-09-24
10827002347806D.A.S.H.G34780DASH-ACRO-35-2602016-09-24

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10827002603407COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
10827002603414COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
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10827002603438COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
10827002603445COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
10827002603452COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
10827002603469COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
10827002603476COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
00733132661664GORE TAG Conformable Thoracic Stent GraftW. L. Gore & Associates, Inc.MIH2025-03-18
00733132661671GORE TAG Conformable Thoracic Stent GraftW. L. Gore & Associates, Inc.MIH2025-03-18
00733132661688GORE TAG Conformable Thoracic Stent GraftW. L. Gore & Associates, Inc.MIH2025-03-18
00733132661695GORE TAG Conformable Thoracic Stent GraftW. L. Gore & Associates, Inc.MIH2025-03-18
10827002601595Zenith AlphaWilliam Cook Europe ApSMIH2024-12-18
10827002601656Zenith AlphaWilliam Cook Europe ApSMIH2024-12-18
10827002601717Zenith AlphaWilliam Cook Europe ApSMIH2024-12-18
10827002601748Zenith AlphaWilliam Cook Europe ApSMIH2024-12-18
10827002601779Zenith AlphaWilliam Cook Europe ApSMIH2024-12-18
10827002601809Zenith AlphaWilliam Cook Europe ApSMIH2024-12-18
10827002601830Zenith AlphaWilliam Cook Europe ApSMIH2024-12-18
10827002601861Zenith AlphaWilliam Cook Europe ApSMIH2024-12-18
10827002601892Zenith AlphaWilliam Cook Europe ApSMIH2024-12-18
10827002601922Zenith AlphaWilliam Cook Europe ApSMIH2024-12-18
10827002601953Zenith AlphaWilliam Cook Europe ApSMIH2024-12-18
10827002601984Zenith AlphaWilliam Cook Europe ApSMIH2024-12-18
10827002602011Zenith AlphaWilliam Cook Europe ApSMIH2024-12-18
10827002602042Zenith AlphaWilliam Cook Europe ApSMIH2024-12-18
10827002602073Zenith AlphaWilliam Cook Europe ApSMIH2024-12-18
10827002602103Zenith AlphaWilliam Cook Europe ApSMIH2024-12-18
10827002602127Zenith AlphaWilliam Cook Europe ApSMIH2024-12-18
10827002602158Zenith AlphaWilliam Cook Europe ApSMIH2024-12-18