FDA.reportPublic FDA data

SpermSelect IUI Kit

Primary DI
60888937003637
Brand
SpermSelect IUI Kit
Company
Coopersurgical, Inc.
Model
SM602-F
Device description
Contents: One SpermSelect System and one Select IUI
Published
2016-08-09
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
HDRCap, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDRCap, CervicalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K900308000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K900308000SPERM SELECT SYSTEMPharmacia, Inc.1990-04-13HDR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
60888937003637PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
6088893700363760888937003637

GMDN Terms#

Term, Definition table
TermDefinition
Spermatozoa/semen motility medium supplementA sterile supplemental solution intended to be added to the medium during semen preparation for use in assisted reproduction technique (ART) procedures so as to enhance semen fluidity and sperm motility. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
801895244
Device count
1
Kit
true
Lot or batch
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05065015660064Béa FertilitySTEPONE FERTILITY LTDHDR2025-07-24
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03700111400559STANDARD INTRA UTERINE INSIMINATION CANNULALABORATOIRE CCDHDR2023-12-05
03700111400566INTRA UTERINE INSEMINATION CANNULA WITH MANDRELLABORATOIRE CCDHDR2023-12-05
03700111400573MEMORY INTRA UTERINE INSIMINATION CANNULALABORATOIRE CCDHDR2023-12-05
03700111400733SPIRETTE®LABORATOIRE CCDHDR2023-12-05
03700111400740MUCAT® STERILELABORATOIRE CCDHDR2023-12-05
10810028774121Frida FertilityFridababy, LLCHDR2023-12-05
03700111425545SMALL GENITOR® INTRA UTERINE INSIMINATION CANNULALABORATOIRE CCDHDR2023-12-05
03700111425552STANDARD INTRA UTERINE INSIMINATION CANNULALABORATOIRE CCDHDR2023-12-05
03700111425569INTRA UTERINE INSEMINATION CANNULA WITH MANDRELLABORATOIRE CCDHDR2023-12-05
03700111425576MEMORY INTRA UTERINE INSIMINATION CANNULALABORATOIRE CCDHDR2023-12-05
03700111425736SPIRETTE®LABORATOIRE CCDHDR2023-12-05
03700111425743MUCAT® STERILELABORATOIRE CCDHDR2023-12-05
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