TheCurve

Primary DI
00888937003604
Brand
TheCurve
Company
Coopersurgical, Inc.
Model
SM507
Device description
Intrauterine Insemination Catheter
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
20888937003608PackageGS125In Commercial Distribution
00888937003604PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088893700360820888937003608
00888937003604008889370036048889370036040888937003604

GMDN Terms#

Term, Definition table
TermDefinition
Assisted reproduction transfer catheter/setA device or collection of devices that includes a flexible polymer tube intended to be used primarily to transfer gametes (eggs or sperm) and/or embryos into the female reproductive tract for the purpose of assisted reproduction [e.g., intrauterine insemination (IUI) or gamete intrafallopian transfer (GIFT)]. In addition to the ‘live transfer’ catheter it may also include a trial transfer catheter intended to assess/ensure that embryo placement will be successful; it typically also includes devices intended to assist catheter introduction (e.g., outer guide sheath, stylet). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length17.2Centimeter
Lumen/Inner Diameter1.1Millimeter
Outer Diameter2.6Millimeter

Regulatory Flags#

DUNS number
801895244
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888937033687ONETRACC1001502026-07-10
00888937033694ONETRACC1001652026-07-10
00888937033700ONETRACC1001702026-07-10
00888937033717ONETRACC1001802026-07-10
00888937033724ONETRACC1001902026-07-10
00888937033731ONETRAC LXC1002102026-07-10
00888937033748ONETRAC LXC1002202026-07-10
00888937033755ONETRAC LXC1002302026-07-10
00888937033762ONETRAC LXC1002402026-07-10
00888937033779ONETRAC LXC1002502026-07-10
00888937033786ONETRAC™ LXSC1002602026-07-10
00888937033793ONETRAC™ LXSC1002702026-07-10
00888937033809ONETRAC™ LXSC1002802026-07-10
00888937033816ONETRAC™ LXSC1002902026-07-10
00888937033823ONETRAC™ LXSC1102002026-07-10
00888937033830ONETRAC™ LXSC1102102026-07-10
00888937033847ONETRAC™ LXSC1102202026-07-10
00888937033854ONETRAC™ LXSC1103102026-07-10
00888937033861ONETRAC™ LXSC1103202026-07-10
00888937033663ONETRAC™C1001102026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812261016603Insemina Intra Uterine Insemination Catheter ALLWIN MEDICAL DEVICES, INC.MFD2020-09-18
00812261016610Stumpy Intra Uterine Insemination CannulaALLWIN MEDICAL DEVICES, INC.MFD2020-09-18
00812261016818Curved Intra Uterine Insemination Catheter ALLWIN MEDICAL DEVICES, INC.MFD2020-09-18
00812261016825Flexi Intra Uterine Insemination CatheterALLWIN MEDICAL DEVICES, INC.MFD2020-09-18
00812261016863Trackable Intra Uterine Insemination Catheter ALLWIN MEDICAL DEVICES, INC.MFD2020-09-18
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
00888937021332Wallace Artificial Insemination CatheterCoopersurgical, Inc.MFD2019-09-26
30888937021333Wallace Artificial Insemination CatheterCoopersurgical, Inc.MFD2019-09-26
35019315071533PneupacICU MEDICAL, INC.MFD2017-01-03
15019315015700WallaceICU MEDICAL, INC.MFD2016-10-05
35019315015704WallaceSmiths Medical International LtdMFD2016-10-05
00827002169449Insemi-CathCOOK INCORPORATEDMFD2016-09-24
00827002169616Insemi-CathCOOK INCORPORATEDMFD2016-09-24
00827002173439Insemi-CathCOOK INCORPORATEDMFD2016-09-24
00827002189522CookCOOK INCORPORATEDMFD2016-09-24
10827002167077Insemi-CathCOOK INCORPORATEDMFD2016-09-24
10827002167862Insemi-CathCOOK INCORPORATEDMFD2016-09-24
10827002169446Insemi-CathCOOK INCORPORATEDMFD2016-09-24
10827002169613Insemi-CathCOOK INCORPORATEDMFD2016-09-24
10827002173436Insemi-CathCOOK INCORPORATEDMFD2016-09-24
00827002179127Soft-PassCOOK INCORPORATEDMFD2016-09-24
00827002181830Soft-PassCOOK INCORPORATEDMFD2016-09-24
00827002181908Soft-PassCOOK INCORPORATEDMFD2016-09-24
10827002189529CookCOOK INCORPORATEDMFD2016-09-24
10827002189536CookCOOK INCORPORATEDMFD2016-09-24
00827002190849Soft-PassCOOK INCORPORATEDMFD2016-09-24
00827002191297Soft-PassCOOK INCORPORATEDMFD2016-09-24