FDA.reportPublic FDA data

Cotton Plugged IVF Pasteur Pipets

Primary DI
50888937014124
Brand
Cotton Plugged IVF Pasteur Pipets
Company
Coopersurgical, Inc.
Model
PP-9-90PL
Device description
"Origio, Inc. 9"" (22.9 cm) Cotton Plugged IVF Pasteur Pipets"
Published
2016-09-23
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

Product Codes#

Code, Name table
CodeName
MQKLabware, Assisted Reproduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQKLabware, Assisted ReproductionObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K000915000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K000915000PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75Humagen Fertility Diagnostics, Inc.2000-05-12MQK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888937014123PackageGS130In Commercial Distribution
50888937014124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088893701412320888937014123
5088893701412450888937014124

GMDN Terms#

Term, Definition table
TermDefinition
User-induced pipetteA device designed for the manual withdrawal, transfer, and injection of small volumes of fluid materials. It is made of glass or plastic and is designed as a long thin tube, typically with graduations along its length. The user will typically attach a mouthpiece and create a partial vacuum within the pipette by gently sucking the air from inside the tube inducing the liquid to enter the pipette, or achieve the same action with a squeezable bulb. Closing the mouthpiece or the user end of the pipette will hold the liquid therein; dispensing is done by controlled venting of air into the user end or squeezing the bulb.

Regulatory Flags#

DUNS number
801895244
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
05060488046858EZ-Strip131µm7-72-1131/202025-04-11
05060488046865EZ-Strip135µm7-72-1135/202025-04-11
05060488046872EZ-Strip145µm7-72-1145/202025-04-11
05060488046889EZ-Strip145µm Long7-72-1145L/202025-04-11
05060488046896EZ-Strip155µm7-72-1170/202025-04-11
05060488046902EZ-Strip170µm7-72-1170/202025-04-11
05060488046919EZ-Strip200µm7-72-1290/202025-04-11
05060488046926EZ-Strip290µm7-72-1290/202025-04-11
05060488046933EZ-Strip290µm7-72-1600/202025-04-11
05060488046940EZ-Tip75µm7-72-2075/12025-04-11
05060488046957EZ-Tip125µm7-72-2125/12025-04-11
05060488046964EZ-Tip135µm7-72-2135/12025-04-11
05060488046971EZ-Tip145µm7-72-2145/12025-04-11
05060488046988EZ-Tip155µm7-72-2155/12025-04-11
05060488046995EZ-Tip170µm7-72-2170/12025-04-11
05060488047008EZ-Tip200µm7-72-2200/12025-04-11
05060488047015EZ-Tip250µm7-72-2250/12025-04-11
05060488047022EZ-Tip290µm7-72/2290/12025-04-11
05060488047039EZ-Tip600µm7-72-2600/12025-04-11
05060488047046EZ-Tip75µm7-72-2075/52025-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888937029048LifeGlobal® GPS® DishwareCoopersurgical, Inc.MQK2026-05-11
00888937029055LifeGlobal® GPS® DishwareCoopersurgical, Inc.MQK2026-05-11
00888937029062LifeGlobal® GPS® DishwareCoopersurgical, Inc.MQK2026-05-11
00888937029079LifeGlobal® GPS® DishwareCoopersurgical, Inc.MQK2026-05-11
00888937029086LifeGlobal® GPS® DishwareCoopersurgical, Inc.MQK2026-05-11
00888937029093LifeGlobal® GPS® DishwareCoopersurgical, Inc.MQK2026-05-11
00888937029109LifeGlobal® GPS® DishwareCoopersurgical, Inc.MQK2026-05-11
06971855770308Minvitro Vitrification StrawGuangzhou Hehong Biotech Co., Ltd.MQK2026-03-10
06971855770315Minvitro Vitrification StrawGuangzhou Hehong Biotech Co., Ltd.MQK2026-03-10
06971855770322Minvitro Vitrification StrawGuangzhou Hehong Biotech Co., Ltd.MQK2026-03-10
06971855770339Minvitro Vitrification StrawGuangzhou Hehong Biotech Co., Ltd.MQK2026-03-10
06971855770377Minvitro Vitrification StrawGuangzhou Hehong Biotech Co., Ltd.MQK2026-03-10
00888937027945ZyMotCoopersurgical, Inc.MQK2026-01-23
00888937027952ZyMotCoopersurgical, Inc.MQK2026-01-23
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B056SCLLG2S-CRYOLOCK(LG)BIOTECH INCORPORATEDMQK2025-12-08
B056CLRCTPK1CRYOLOCK(PK)BIOTECH INCORPORATEDMQK2025-10-27
B056CLRCTPR1CRYOLOCK(PR)BIOTECH INCORPORATEDMQK2025-10-27
B056SCLPK1S-CRYOLOCK (PK)BIOTECH INCORPORATEDMQK2025-10-27
B056SCLPR1S-CRYOLOCK (PR)BIOTECH INCORPORATEDMQK2025-10-27
20888937025860PICSI®Coopersurgical, Inc.MQK2025-10-20
06975183900017Hariomed culture dishHua Yue Medical Technology Co., Ltd.MQK2025-09-30
06975183900185Harioculture TL-16 Time-lapse IncubatorHua Yue Medical Technology Co., Ltd.MQK2025-09-30
06975183900192Time-lapse Incubator Capacity Expansion ModuleHua Yue Medical Technology Co., Ltd.MQK2025-09-30
06975183900208Hariomed humidification boxHua Yue Medical Technology Co., Ltd.MQK2025-09-30
00810195240002cryo-GO Vitrification Device - Red (Pack of 10)IRVINE SCIENTIFIC, LLCMQK2025-06-02
00810195240019cryo-GO Vitrification Device - Yellow (Pack of 10)IRVINE SCIENTIFIC, LLCMQK2025-06-02
00810195240026cryo-GO Vitrification Device - Blue (Pack of 10)IRVINE SCIENTIFIC, LLCMQK2025-06-02