FDA.reportPublic FDA data

Cook

Primary DI
00827002273993
Brand
Cook
Company
COOK INCORPORATED
Model
G27399
Catalog number
DTN-18-25.0
Device description
Trocar Needle
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRCTrocar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRCTrocarCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002273993PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002273993008270022739938270022739930827002273993

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, Specify00

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
042823948
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00827002007475CookG00747T9.0-65-45-M-NS-TJC2016-09-24
00827002071261CookG07126T9.0-65-45-NM-NS-TJC2016-09-24
00827002342538AprimaG34253NSSW-4.0-18-NPAS-100-HC-SST2020-10-15
00827002067622CookG06762PLVW-5.5-25-PICS2020-10-02
00827002116306ChaitG11630CTU10.0-18-CAA2020-10-02
00827002577862Check-Flo PerformerG57786RCF-4.0-21-7-J-012020-07-07
00827002577879Check-Flo PerformerG57787RCF-4.0-35-J-012020-07-07
00827002577886Check-Flo PerformerG57788RCF-5.0-35-J-012020-07-07
00827002577893Check-Flo PerformerG57789RCF-5.0-38-J-012020-07-07
00827002577909Check-Flo PerformerG57790RCF-6.0-35-J-012020-07-07
00827002577916Check-Flo PerformerG57791RCF-6.0-38-J-012020-07-07
00827002577923Check-Flo PerformerG57792RCF-7.0-35-J-012020-07-07
00827002577930Check-Flo PerformerG57793RCF-7.0-38-J-012020-07-07
00827002577947Check-Flo PerformerG57794RCF-8.0-38-J-012020-07-07
00827002577954Check-Flo PerformerG57795RCFP-5.5-25-J-012020-07-07
00827002577961Check-Flo PerformerG57796RCFW-5.0-35-012020-07-07
00827002275010TurcotteG27501HDC-500-TURCOTTE-0429922016-09-24
00827002275027TurcotteG27502HDC-600-TURCOTTE-0429922016-09-24
00827002313941VertefixG31394VBC-1002016-04-28
00827002363922ChaitG36392TDCS-100-M2016-09-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10884450736033Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
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00810212933825SURGIPROSSurgipros, LLCDRC2026-07-28
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00810212933849SURGIPROSSurgipros, LLCDRC2026-07-28