FDA.reportPublic FDA data

Micropuncture

Primary DI
00827002535756
Brand
Micropuncture
Company
COOK INCORPORATED
Model
G53575
Catalog number
JCD4.0-18-10.0-MPIS-SC-SST
Device description
Micropuncture, Push-Plus Stiffened Cannula 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
DREDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DREDilator, Vessel, For Percutaneous CatheterizationCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002535756PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002535756008270025357568270025357560827002535756

Storage And Handling#

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

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
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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