FDA.reportPublic FDA data

Cook

Primary DI
00827002327993
Brand
Cook
Company
Cook Vandergrift Inc.
Model
G32799
Catalog number
K-EBPH-3535
Device description
Blastomere Aspiration Pipette (Embryo Biopsy Pipette)
Published
2016-09-24
Public version status
Update
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
MQHMICROTOOLS, ASSISTED REPRODUCTION (PIPETTES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQHMicrotools, Assisted Reproduction (Pipettes)Obstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10827002327990PackageGS110In Commercial Distribution
00827002327993PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1082700232799010827002327990
00827002327993008270023279938270023279930827002327993

GMDN Terms#

Term, Definition table
TermDefinition
User-induced micropipetteA long, thin tube made of glass or plastic typically used in the laboratory for the manual withdrawal, transfer, and injection of minute volumes of fluid materials (e.g., microlitres or smaller). The user will typically attach a mouthpiece and create a partial vacuum within the device by gently sucking the air from inside the tube, inducing the substance to enter the device, or achieve the same action with a sqeezable bulb/syringe. Closing the mouthpiece or the user end of the pipette will hold the substance therein; dispensing is done by controlled venting of air into the user end or squeezing the bulb/syringe. Device use may include in vitro fertilization (IVF) procedures.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, dry, cool place.

Contacts#

Phone, Email table
PhoneEmail
+1(812)330-5494sharedservices@cookmedical.com

Regulatory Flags#

DUNS number
056867526
Device count
1
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
00827002260573Cook FlexipetG26057K-FPIP-1600-10BS-52016-09-24
00827002267114Cook FlexipetG26711K-FPIP-1130-10BS-52016-09-24
00827002267121Cook FlexipetG26712K-FPIP-1140-10BS-52016-09-24
00827002267138Cook FlexipetG26713K-FPIP-1170-10BS-52016-09-24
00827002327955CookG32795K-EBPH-30352016-09-24
00827002460171Cook FlexipetG46017K-FPIP-1300-102016-09-24
00827002460188Cook FlexipetG46018K-FPIP-1170-102016-09-24
00827002460195Cook FlexipetG46019K-FPIP-1140-102016-09-24
00827002460201Cook FlexipetG46020K-FPIP-1300-10BS-52016-09-24
00827002460218Cook FlexipetG46021K-FPIP-1120-10BS-52016-09-24
10827002188782Cook FlexipetG18878K-FPIP-1300-10BS2016-09-24
10827002261812Cook FlexipetG26181K-FPIP-1080-10BS2016-09-24
10827002267180Cook FlexipetG26718K-FPIP-1100-10BS2016-09-24
00827002609891COOKG60989K-EBPH-20302025-07-24
00827002610132COOKG61013K-EBPH-20352025-07-24
00827002610149COOKG61014K-EBPH-25302025-07-24
00827002610156COOKG61015K-EBPH-25352025-07-24
10827002609898COOKG60989K-EBPH-20302025-07-24
10827002610139COOKG61013K-EBPH-20352025-07-24
10827002610146COOKG61014K-EBPH-25302025-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060488046858EZ-StripCoopersurgical, Inc.MQH2025-04-11
05060488046865EZ-StripCoopersurgical, Inc.MQH2025-04-11
05060488046872EZ-StripCoopersurgical, Inc.MQH2025-04-11
05060488046889EZ-StripCoopersurgical, Inc.MQH2025-04-11
05060488046896EZ-StripCoopersurgical, Inc.MQH2025-04-11
05060488046902EZ-StripCoopersurgical, Inc.MQH2025-04-11
05060488046919EZ-StripCoopersurgical, Inc.MQH2025-04-11
05060488046926EZ-StripCoopersurgical, Inc.MQH2025-04-11
05060488046933EZ-StripCoopersurgical, Inc.MQH2025-04-11
05060488046940EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488046957EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488046964EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488046971EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488046988EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488046995EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047008EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047015EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047022EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047039EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047046EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047053EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047060EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047077EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047084EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047091EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047107EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047114EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047121EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047138EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047145EZ-TipCoopersurgical, Inc.MQH2025-04-11