FDA.reportPublic FDA data

Cook

Primary DI
00827002485273
Brand
Cook
Company
COOK INCORPORATED
Model
G48527
Catalog number
J-FB-100
Device description
Cook Fistula Brush Anal Recto Vaginal Fistula
Published
2020-10-02
Public version status
New
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
GEDBRUSH, DERMABRASION, MANUAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEDBrush, Dermabrasion, ManualGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002485273PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002485273008270024852738270024852730827002485273

GMDN Terms#

Term, Definition table
TermDefinition
Torque manipulation deviceA sterile hand-operated device intended to be attached to the proximal end of an invasive device (e.g., a catheter, a needle, or a guidewire) to provide the operator with the ability to manually manipulate and control the directional torque (rotation) of the device to which it is attached. This device may be made of plastic or metal materials. 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
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30197344029680MEDLINEMEDLINE INDUSTRIES, INC.GED2024-07-11
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00630094188263Bioseal Inc.BIOSEALGED2023-10-05
00630094188300Bioseal Inc.BIOSEALGED2023-10-05
00630094188409Bioseal Inc.BIOSEALGED2023-10-05
00630094188706Bioseal Inc.BIOSEALGED2023-10-05
00630094188904Bioseal Inc.BIOSEALGED2023-10-05
00630094188911Bioseal Inc.BIOSEALGED2023-10-05
00630094188928Bioseal Inc.BIOSEALGED2023-10-05
00630094188935Bioseal Inc.BIOSEALGED2023-10-05
10630094188253Bioseal Inc.BIOSEALGED2023-10-05
10630094188260Bioseal Inc.BIOSEALGED2023-10-05
10630094188307Bioseal Inc.BIOSEALGED2023-10-05
10630094188406Bioseal Inc.BIOSEALGED2023-10-05
10630094188703Bioseal Inc.BIOSEALGED2023-10-05
10630094188901Bioseal Inc.BIOSEALGED2023-10-05
10630094188918Bioseal Inc.BIOSEALGED2023-10-05
10630094188925Bioseal Inc.BIOSEALGED2023-10-05
10630094188932Bioseal Inc.BIOSEALGED2023-10-05
00850019947847Dermal Cooling SystemR2 Technologies, Inc.GED2023-06-09
00850019947878Dermal Cooling SystemR2 Technologies, Inc.GED2023-06-09
00850019947632Dermal Cooling SystemR2 DERMATOLOGY INC.GED2023-06-09
B7687834600Buxton BioMedicalBuxton Biomedical IncGED2023-01-10
00860371002306Norsen Debrider, SterileBEL-MED, INC.GED2019-05-29