FDA.reportPublic FDA data

Cook

Primary DI
00827002613553
Brand
Cook
Company
COOK INCORPORATED
Model
G61355
Catalog number
SDN-18-9.0-UM
Device description
Percutaneous Entry Thinwall Needle One-Part
Published
2026-10-22
Public version status
New
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
JOLCATHETER AND TIP, SUCTION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOLCatheter And Tip, SuctionGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002613553PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002613553008270026135538270026135530827002613553

GMDN Terms#

Term, Definition table
TermDefinition
Hypodermic needle, single-useA non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.

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
00827002606616OpTUS Ultra PleuralG60661OPTUS-SET-5.5-15-PIGTAIL2026-10-22
00827002606623OpTUS Ultra PleuralG60662OPTUS-TRAY-5.5-15-PIGTAIL2026-10-22
00827002606630OpTUS Ultra PleuralG60663OPTUS-SET-8.5-20-PIGTAIL2026-10-22
00827002606647OpTUS Ultra PleuralG60664OPTUS-TRAY-8.5-20-PIGTAIL2026-10-22
00827002606654OpTUS Ultra PleuralG60665OPTUS-SET-10-20-PIGTAIL2026-10-22
00827002606661OpTUS Ultra PleuralG60666OPTUS-TRAY-10-20-PIGTAIL2026-10-22
00827002606678OpTUS Ultra PleuralG60667OPTUS-SET-12-30-STRAIGHT2026-10-22
00827002606685OpTUS Ultra PleuralG60668OPTUS-TRAY-12-30-STRAIGHT2026-10-22
00827002606692OpTUS Ultra PleuralG60669OPTUS-SET-12-30-PIGTAIL2026-10-22
00827002606708OpTUS Ultra PleuralG60670OPTUS-TRAY-12-30-PIGTAIL2026-10-22
00827002606715OpTUS Ultra PleuralG60671OPTUS-SET-14-30-STRAIGHT2026-10-22
00827002606722OpTUS Ultra PleuralG60672OPTUS-TRAY-14-30-STRAIGHT2026-10-22
00827002606739OpTUS Ultra PleuralG60673OPTUS-SET-14-30-PIGTAIL2026-10-22
00827002606746OpTUS Ultra PleuralG60674OPTUS-TRAY-14-30-PIGTAIL2026-10-22
00827002606753OpTUS Ultra PleuralG60675OPTUS-SET-16-30-STRAIGHT2026-10-22
00827002606760OpTUS Ultra PleuralG60676OPTUS-TRAY-16-30-STRAIGHT2026-10-22
00827002606777OpTUS Ultra PleuralG60677OPTUS-SET-16-30-PIGTAIL2026-10-22
00827002606784OpTUS Ultra PleuralG60678OPTUS-TRAY-16-30-PIGTAIL2026-10-22
00827002606791OpTUS Ultra PleuralG60679OPTUS-SET-20-30-STRAIGHT2026-10-22
00827002606807OpTUS Ultra PleuralG60680OPTUS-TRAY-20-30-STRAIGHT2026-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00827002606616OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606623OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606630OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606647OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606654OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606661OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606678OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606685OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606692OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606708OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606715OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606722OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606739OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606746OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606753OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606760OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606777OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606784OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606791OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606807OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606814OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606821OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00190776436384MillenniumAvalign Technologies, Inc.JOL2026-10-08
00190776436391MillenniumAvalign Technologies, Inc.JOL2026-10-08
00190776436407MillenniumAvalign Technologies, Inc.JOL2026-10-08
00190776436414MillenniumAvalign Technologies, Inc.JOL2026-10-08
00190776436421MillenniumAvalign Technologies, Inc.JOL2026-10-08
00190776436469MilleniumAvalign Technologies, Inc.JOL2026-10-08
00190776436476MilleniumAvalign Technologies, Inc.JOL2026-10-08
00190776436483MilleniumAvalign Technologies, Inc.JOL2026-10-08