FDA.reportPublic FDA data

Entuit

Primary DI
10827002472898
Brand
Entuit
Company
COOK INCORPORATED
Model
G47289
Catalog number
C-ENTUIT-16-M
Device description
Entuit Gastrostomy Set
Published
2020-08-21
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
PRRFeeding tube kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PRRFeeding Tube KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10827002472898PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1082700247289810827002472898

GMDN Terms#

Term, Definition table
TermDefinition
Gastrostomy tube kit, non-medicatedA collection of devices which includes a gastrostomy tube with additional surgical devices intended to create short- and/or long-term (= 24 hours) access to the stomach via a gastrostomy. In addition to the gastrostomy tube, the kit includes surgical cutting devices (e.g., scalpel) intended to perform the gastrostomy, and devices intended for tube introduction/function (e.g., introduction needle, guidewire, dilator, fastener, lubricant); it does not include any pharmaceutical agents. 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
Kit
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
10198956222090CARDINAL HEALTHCardinal Health 200, LLCPRR2025-11-02
10197106583913CARDINAL HEALTHCardinal Health 200, LLCPRR2024-04-16
50197106583911CARDINAL HEALTHCardinal Health 200, LLCPRR2024-04-16
10827002472843EntuitCOOK INCORPORATEDPRR2020-08-21
10827002472850EntuitCOOK INCORPORATEDPRR2020-08-21
10827002472867EntuitCOOK INCORPORATEDPRR2020-08-21
10827002472874EntuitCOOK INCORPORATEDPRR2020-08-21
10827002472881EntuitCOOK INCORPORATEDPRR2020-08-21
10827002472904EntuitCOOK INCORPORATEDPRR2020-08-21
10827002472911EntuitCOOK INCORPORATEDPRR2020-08-21
10193489782646MEDLINEMEDLINE INDUSTRIES, INC.PRR2020-05-18
20193489782643MEDLINEMEDLINE INDUSTRIES, INC.PRR2020-05-18
10193489191776MEDLINEMEDLINE INDUSTRIES, INC.PRR2020-04-15
20193489191773MEDLINEMEDLINE INDUSTRIES, INC.PRR2020-04-15
00653160056952CenturionCENTURION MEDICAL PRODUCTS CORPORATIONPRR2016-09-13
50653160056957CenturionCENTURION MEDICAL PRODUCTS CORPORATIONPRR2016-09-13