SpermSelect Curve Kit

Primary DI
60888937003644
Brand
SpermSelect Curve Kit
Company
Coopersurgical, Inc.
Model
SM603-F
Device description
Contents: One SpermSelect System and one TheCurve
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
MFDCannula, Intrauterine Insemination

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MFDCannula, Intrauterine InseminationObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012935000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012935000THECURVE, ITEM 507Select Medical Systems, Inc.2001-10-11MFD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
60888937003644PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
6088893700364460888937003644

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
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00888937028546LifeGlobal® MediaLGGF-100MLGGF-100M2026-05-11
00888937028614LifeGlobal® MediaGCOL-100MGCOL-100M2026-05-11
00888937028621LifeGlobal® MediaGCOL-500MGCOL-500M2026-05-11
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00888937028645LifeGlobal® MediaLGOL-500MLGOL-500M2026-05-11
00888937028652LifeGlobal® MediaAMLO-100MAMLO-100M2026-05-11
00888937028669LifeGlobal® MediaLGPO-100MLGPO-100M2026-05-11
00888937028676LifeGlobal® MediaLGPO-500MLGPO-500M2026-05-11
00888937028683LifeGlobal® MediaAMPO-100MAMPO-100M2026-05-11
00888937028690LifeGlobal® MediaLGUA-100MLGUA-100M2026-05-11
00888937028706LifeGlobal® MediaLGUA-500MLGUA-500M2026-05-11
00888937028713LifeGlobal® MediaAMLG-100MAMLG-100M2026-05-11
00888937028935LifeGlobal® MediaH5TH-050MH5TH-050M2026-05-11
00888937028942LifeGlobal® MediaH5TH-100MH5TH-100M2026-05-11
00888937029017LifeGlobal® MediaLGGH-050MLGGH-050M2026-05-11
00888937029024LifeGlobal® MediaLGGH-100MLGGH-100M2026-05-11

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Primary DI, Brand, Company table
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00812261016818Curved Intra Uterine Insemination Catheter ALLWIN MEDICAL DEVICES, INC.MFD2020-09-18
00812261016825Flexi Intra Uterine Insemination CatheterALLWIN MEDICAL DEVICES, INC.MFD2020-09-18
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00819374021814Insemina Open Tip Intra Uterine Insemination Catheter ALLWIN MEDICAL DEVICES, INC.MFD2020-09-18
00819374021890Curved Insemina Intra Uterine Insemination Catheter Open TipALLWIN MEDICAL DEVICES, INC.MFD2020-09-18
00819374022019Trackable Intra Uterine Insemination Catheter Open TipALLWIN MEDICAL DEVICES, INC.MFD2020-09-18
00819374022491Flexi Intra Uterine Insemination Catheter Open TipALLWIN MEDICAL DEVICES, INC.MFD2020-09-18
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