FDA.reportPublic FDA data

Cook

Primary DI
00827002272606
Brand
Cook
Company
COOK INCORPORATED
Model
G27260
Catalog number
ADN-22-7.0
Device description
Percutaneous Entry Thinwall Needle Catheter Access
Published
2017-08-09
Public version status
Update
Distribution status
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
00827002272606PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002272606008270022726068270022726060827002272606

GMDN Terms#

Term, Definition table
TermDefinition
Abdominal paracentesis needle, single-useA sterile, sharp bevel-edged, hollow tubular metal instrument used to perform therapeutic or diagnostic aspiration of fluids/air from the abdominal cavity. It may be used for the placement/operation of a paracentesis catheter or used directly without a catheter. It is typically made of high-grade stainless steel and may have an attached stopcock to control the aspiration process. The device is commonly used to remove ascites fluid from the peritoneal cavity. 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
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
00827002000766CookG00076MDC-62020-10-02
00827002000773CookG00077MDC-72020-10-02
00827002000780CookG00078MDC-82020-10-02
00827002009653CookG00965MDC-102020-10-02
00827002009660CookG00966MDC-52020-10-02
00827002010796CookG01079MDC-92020-10-02
00827002013209CookG01320MDC-122020-10-02
00827002014626CookG01462MDC-142020-10-02
00827002016170CookG01617MDC-162020-10-02
00827002026896CookG02689MDC-42020-10-02
00827002027350CookG02735MDC-32020-10-02
00827002048881CookG04888FD-1002020-10-02
00827002541900GuardiaG54190J-UOB-40282016-09-24
00827002541917GuardiaG54191J-UOB-4028-ST2016-09-24
00827002614994MagniCoreG61499MRCHN-20-15.02026-03-27
00827002615007MagniCoreG61500MRCHN-18-10.02026-03-27
00827002615014MagniCoreG61501MRCHN-18-15.02026-03-27
00827002615021MagniCoreG61502MRCHN-18-20.02026-03-27
00827002615038MagniCoreG61503MRCHN-20-10.02026-03-27
00827002615045MagniCoreG61504MRCHN-20-20.02026-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888867500914Arthrex®ARTHREX, INC.DRC2026-03-13
04262494463594N/ADoppkon GmbH & Co. KGDRC2025-09-12
04262494463631N/ADoppkon GmbH & Co. KGDRC2025-09-12
04262494463785N/ADoppkon GmbH & Co. KGDRC2025-09-12
04262494463792N/ADoppkon GmbH & Co. KGDRC2025-09-12
04262494463808N/ADoppkon GmbH & Co. KGDRC2025-09-12
04262494463815N/ADoppkon GmbH & Co. KGDRC2025-09-12
04262494463822N/ADoppkon GmbH & Co. KGDRC2025-09-12
04262494463839N/ADoppkon GmbH & Co. KGDRC2025-09-12
04262494463846N/ADoppkon GmbH & Co. KGDRC2025-09-12
04262494461064N/ADoppkon GmbH & Co. KGDRC2025-08-05
04262494461224N/ADoppkon GmbH & Co. KGDRC2025-08-05
04262494461019N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461026N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461033N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461040N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461057N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461071N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461088N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461095N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461101N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461118N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461125N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461132N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461149N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461156N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461163N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461170N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461187N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461194N/ADoppkon GmbH & Co. KGDRC2025-08-04