FDA.reportPublic FDA data

Cook

Primary DI
00827002170568
Brand
Cook
Company
COOK INCORPORATED
Model
G17056
Catalog number
050004-S3
Device description
Endoscopic Cap
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
KNSUnit, electrosurgical, endoscopic (with or without accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)Gastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002170568PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002170568008270021705688270021705680827002170568

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose catheter connector, sterileA small sterile device intended to create a mechanical union between a catheter and an external device (non-dedicated) typically via a Luer connection; it has an intended use profile that is not dedicated to a specific type of catheter (i.e., can be applied to catheters specific to different anatomical sites and body fluids). It may be used to permit catheter insertion and/or manipulation, and/or to facilitate delivery or extraction of substances through the catheter lumen. 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
DM exempt
false
Premarket exempt
false
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
00827002613508SureTome SWG61350SUR-SW-352025-12-08
10827002613512SureTome SWG61351SUR-SW-AWG2-35-2602025-12-08
10827002613529SureTome SWG61352SUR-SW-AWG2-35-4502025-12-08
10827002242378BakriG24237J-SOSR-1005002016-09-24
10827002306735BakriG30673J-SOS-1005002016-09-24
00827002607842COOKG60784TESLA-B2535-2602025-07-22
00827002607859COOKG60785TESLA-B2535-4502025-07-22
10827002597508COOKG59750TESLA-B-ACU2025-07-11
10827002496535Cotton-Leung Sof-FlexG49653CLSO-SF-10-52015-11-03
00827002352674HerculesG35267HBDE-W-8-9-102022-12-20
00827002352681HerculesG35268HBDE-W-10-11-122022-12-20
00827002352698HerculesG35269HBDE-W-12-13.5-152022-12-20
00827002352704HerculesG35270HBDE-W-15-16.5-182022-12-20
00827002352711HerculesG35271HBDE-W-18-19-202022-12-20
10827002346014FusionG34601FS-OMNI-ACRO-35-2052016-09-24
10827002346939FusionG34693FS-OMNI-ACRO-35-2602016-09-24
10827002347110FusionG34711FS-OMNI-ACRO-35-4502016-09-24
10827002347783D.A.S.H.G34778DASH-ACRO-35-4502016-09-24
10827002347790D.A.S.H.G34779DASH-ACRO-25-4502016-09-24
10827002347806D.A.S.H.G34780DASH-ACRO-35-2602016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16932503512227Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-08
16932503512210Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512234Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512241Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512258Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512265Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512272Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512289Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512296Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512302Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512319Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512326Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512333Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512340Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512357Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512364Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512371Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512388Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512395Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512401Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512418Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503513187Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503513194Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503513200Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
14953170466349Single Use 3-Lumen Needle Knife VOLYMPUS MEDICAL SYSTEMS CORP.KNS2025-12-18
14953170466356Single Use 3-Lumen Needle Knife VOLYMPUS MEDICAL SYSTEMS CORP.KNS2025-12-18
00827002613508SureTome SWCOOK INCORPORATEDKNS2025-12-08
10827002613512SureTome SWCOOK INCORPORATEDKNS2025-12-08
10827002613529SureTome SWCOOK INCORPORATEDKNS2025-12-08
00827002607842COOKCOOK INCORPORATEDKNS2025-07-22