FDA.reportPublic FDA data

Cook

Primary DI
00827002171688
Brand
Cook
Company
COOK INCORPORATED
Model
G17168
Catalog number
056002
Device description
Silicone Penrose Drain
Published
2020-10-02
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
GCYAPPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCYApparatus, Suction, Single Patient Use, Portable, NonpoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002171688PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002171688008270021716888270021716880827002171688

GMDN Terms#

Term, Definition table
TermDefinition
Surgical capillary wound drain, luminal, synthetic polymerA sterile device with a lumen(s) designed to establish a passive egress for the removal of fluid (drainage of blood, lymph, exudate) from a surgical wound to minimize its accumulation and risk of wound infection; it is not dedicated to a particular anatomical wound. It is typically inserted into the wound by a surgeon in the operating room (OR) after the completion of an inpatient or outpatient procedure. It is typically made of radiopaque silicone and is available in various forms (e.g., Penrose type, tubular with side holes, multi-tubular). 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
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
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

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Primary DI, Brand, Company table
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10848530106277Tracheostomy and Suction AccessorySUNSET HEALTHCARE SOLUTIONS, INC.GCY2025-06-03
00860013965303Cobb-XLR Excellerator™5TH INTERVAL MEDICAL LLCGCY2025-05-05
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50198956012767CARDINAL HEALTHCardinal Health 200, LLCGCY2025-03-26
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10840306831048Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.GCY2024-12-12
10840306836081Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.GCY2024-12-12
10840306836098Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.GCY2024-12-12
00817640021704Tru-Close Suction Drainage SystemURESIL, LLCGCY2024-11-11