FDA.reportPublic FDA data

Silhouette

Primary DI
00827002270053
Brand
Silhouette
Company
COOK INCORPORATED
Model
G27005
Catalog number
PLVTW-16.0-38-13
Device description
Silhouette, Transitionless Peel-Away, Introducer
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGZACCESSORIES, CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGZAccessories, CatheterGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002270053PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002270053008270022700538270022700530827002270053

GMDN Terms#

Term, Definition table
TermDefinition
Interventional radiology percutaneous-access procedure kitA collection of various sterile radiopaque instruments/devices (e.g., introducer sheath, dilator, needle, angiographic catheter) intended to be used for image-guided, single-puncture, percutaneous access to facilitate an interventional radiology procedure (e.g., bile duct biopsy, percutaneous transhepatic cholangiogram, non-vascular drainage procedures). It does not contain pharmaceuticals. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, dry, cool place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(812)330-5494sharedservices@cookmedical.com

Regulatory Flags#

DUNS number
042823948
Device count
1
DM exempt
false
Premarket exempt
true
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00827002613508SureTome SWG61350SUR-SW-352025-12-08
10827002613512SureTome SWG61351SUR-SW-AWG2-35-2602025-12-08
10827002613529SureTome SWG61352SUR-SW-AWG2-35-4502025-12-08
10827002242378BakriG24237J-SOSR-1005002016-09-24
10827002306735BakriG30673J-SOS-1005002016-09-24
00827002607842COOKG60784TESLA-B2535-2602025-07-22
00827002607859COOKG60785TESLA-B2535-4502025-07-22
10827002597508COOKG59750TESLA-B-ACU2025-07-11
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20653160392375Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KGZ2026-02-26
06937440443811YiGaoMedZhejiang Yigao Medical Technology Co., Ltd.KGZ2025-12-09
06937440443828YiGaoMedZhejiang Yigao Medical Technology Co., Ltd.KGZ2025-12-09
40198459435202MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGZ2025-07-21
40704411017883AMSure® Single Spike Infiltration TubingAMSINO INTERNATIONAL, INC.KGZ2025-06-23
04048223118702FixoLongPajunk GmbH MedizintechnologieKGZ2025-04-04
05708932767811SopranoColoplast A/SKGZ2025-03-26
20192253053606DevonCardinal Health 200, LLCKGZ2025-03-25
20192253042020DevonCardinal Health 200, LLCKGZ2025-03-07
20192253042037DevonCardinal Health 200, LLCKGZ2025-03-07
00840306834936Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-12-11
00840306835155Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-12-11
00840306835124Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-12-10
00860012804405BladeClearPATHWAY MEDTECH, LLCKGZ2024-11-04
00860012804412BladeClearPATHWAY MEDTECH, LLCKGZ2024-11-04
00840306836039Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-10-23
10884521811546RitusCovidien LPKGZ2024-10-21
00840306835162Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-10-10
00840306835179Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-10-10
00840306835186Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-10-10
00840306835209Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-10-10
00840306835216Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-10-10
00840306835223Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-10-10
00840306835230Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-10-10
00840306835247Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-10-10
05708932767545Insertion ToolCOLOPLAST CORP.KGZ2024-09-27
50382904275650BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-22
50382904275612BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-20
50382904275629BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-20
50382904275636BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-20