Cook

Primary DI
00827002179202
Brand
Cook
Company
COOK INCORPORATED
Model
G17920
Catalog number
FG-038080
Device description
Filiform Guidewire For Use With Philips Follower Dilator
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

Related Records

Contact Domains

Product Codes

CodeName
FBWFILIFORM AND FILIFORM FOLLOWER

Product Code Classifications

CodeDeviceSpecialtyClass
FBWFiliform And Filiform FollowerGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00827002179202PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002179202008270021792028270021792020827002179202

GMDN Terms

TermDefinition
Gastro-urological guidewire, single-useA sterile metal coil or wire intended to assist the insertion/positioning of a diagnostic/therapeutic device(s) [e.g., endoscope, catheter] within the gastrointestinal (GI) and/or urinary tract. It is typically coated with a plastic material [e.g., polytetrafluoroethylene (PTFE), commonly known as Teflon, or polyethylene (PE)]. It may have radiopaque graduated markings at the distal end to assist in the fluoroscopic monitoring of its advancement/position within the body. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, dry, cool place.

Sterilization Methods

Method

Contacts

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

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10827002306735BakriG30673J-SOS-1005002016-09-24
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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 DIBrandCompanyProduct codePublished
00827002141001CookCOOK INCORPORATEDFBW2020-10-15
00827002141018CookCOOK INCORPORATEDFBW2020-10-02
00827002141025CookCOOK INCORPORATEDFBW2020-10-02
00827002141032CookCOOK INCORPORATEDFBW2020-10-02
00827002141049CookCOOK INCORPORATEDFBW2020-10-02
00827002141056CookCOOK INCORPORATEDFBW2020-10-02
00827002141063CookCOOK INCORPORATEDFBW2020-10-02
00827002141070CookCOOK INCORPORATEDFBW2020-10-02
00827002141087CookCOOK INCORPORATEDFBW2020-10-02
00827002141094CookCOOK INCORPORATEDFBW2020-10-02
00827002141100CookCOOK INCORPORATEDFBW2020-10-02
00827002141117CookCOOK INCORPORATEDFBW2020-10-02
00827002141124CookCOOK INCORPORATEDFBW2020-10-02
00827002141131CookCOOK INCORPORATEDFBW2020-10-02
00827002141148CookCOOK INCORPORATEDFBW2020-10-02
00827002144774CookCOOK INCORPORATEDFBW2020-10-02
00827002147409CookCOOK INCORPORATEDFBW2020-10-02
00827002151086CookCOOK INCORPORATEDFBW2020-10-02
00827002151093CookCOOK INCORPORATEDFBW2020-10-02
00827002152052CookCOOK INCORPORATEDFBW2020-10-02
00827002179097CookCOOK INCORPORATEDFBW2020-10-02
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00801741073137Woven Filiform Spiral TipC. R. Bard, Inc.FBW2020-09-04
00801741073144Woven Filiform Spiral TipC. R. Bard, Inc.FBW2020-09-04
00801741073151Woven Filiform Spiral TipC. R. Bard, Inc.FBW2020-09-04
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