Cook

Primary DI
00827002141124
Brand
Cook
Company
COOK INCORPORATED
Model
G14112
Catalog number
110120
Device description
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
00827002141124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002141124008270021411248270021411240827002141124

GMDN Terms

TermDefinition
Endoscopic-access dilator, single-useA device intended to be used to dilate a body lumen or access channel to facilitate the introduction of endoscopic instruments percutaneously (through the skin) or through a natural orifice (e.g., urethra). It may be a flexible or rigid rod/tube with a tapered distal tip. 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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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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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
00827002141131CookCOOK INCORPORATEDFBW2020-10-02
00827002141148CookCOOK INCORPORATEDFBW2020-10-02
00827002144774CookCOOK INCORPORATEDFBW2020-10-02
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00827002151093CookCOOK INCORPORATEDFBW2020-10-02
00827002152052CookCOOK INCORPORATEDFBW2020-10-02
00827002179097CookCOOK INCORPORATEDFBW2020-10-02
00827002179202CookCOOK INCORPORATEDFBW2020-10-02
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