FDA.reportPublic FDA data

Shepard

Primary DI
10827002164533
Brand
Shepard
Company
COOK INCORPORATED
Model
G16453
Catalog number
J-IUIE-541008
Device description
Shepard Intrauterine Insemination Set
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HDRCAP, CERVICAL

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10827002164533PackageGS120In Commercial Distribution
00827002164536PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1082700216453310827002164533
00827002164536008270021645368270021645360827002164536

GMDN Terms#

Term, Definition table
TermDefinition
Assisted reproduction catheter setA collection of sterile devices 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)], a procedure that may be administered transvaginally or laparoscopically. It typically consists of a transfer catheter and an outer guide sheath, or an inner and outer catheter; a stylet may be included to aid passage through the cervix. Some sets may include a trial transfer catheter set to assess/ensure that embryo placement will be successful. This is a single-use device.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
042823948
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00827002000766CookG00076MDC-62020-10-02
00827002000773CookG00077MDC-72020-10-02
00827002000780CookG00078MDC-82020-10-02
00827002009653CookG00965MDC-102020-10-02
00827002009660CookG00966MDC-52020-10-02
00827002010796CookG01079MDC-92020-10-02
00827002013209CookG01320MDC-122020-10-02
00827002014626CookG01462MDC-142020-10-02
00827002016170CookG01617MDC-162020-10-02
00827002026896CookG02689MDC-42020-10-02
00827002027350CookG02735MDC-32020-10-02
00827002048881CookG04888FD-1002020-10-02
00827002541900GuardiaG54190J-UOB-40282016-09-24
00827002541917GuardiaG54191J-UOB-4028-ST2016-09-24
00827002614994MagniCoreG61499MRCHN-20-15.02026-03-27
00827002615007MagniCoreG61500MRCHN-18-10.02026-03-27
00827002615014MagniCoreG61501MRCHN-18-15.02026-03-27
00827002615021MagniCoreG61502MRCHN-18-20.02026-03-27
00827002615038MagniCoreG61503MRCHN-20-10.02026-03-27
00827002615045MagniCoreG61504MRCHN-20-20.02026-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05065015660002Béa FertilitySTEPONE FERTILITY LTDHDR2025-07-24
05065015660064Béa FertilitySTEPONE FERTILITY LTDHDR2025-07-24
00810028774124Frida FertilityFridababy, LLCHDR2023-12-05
03700111400542SMALL GENITOR® INTRA UTERINE INSIMINATION CANNULALABORATOIRE CCDHDR2023-12-05
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
00827002164529ShepardCOOK INCORPORATEDHDR2016-09-24
00827002164536ShepardCOOK INCORPORATEDHDR2016-09-24
00827002164543ShepardCOOK INCORPORATEDHDR2016-09-24
00827002164581ShepardCOOK INCORPORATEDHDR2016-09-24
00827002164635ShepardCOOK INCORPORATEDHDR2016-09-24
00827002164642ShepardCOOK INCORPORATEDHDR2016-09-24
00827002164680ShepardCOOK INCORPORATEDHDR2016-09-24
00827002164697ShepardCOOK INCORPORATEDHDR2016-09-24
00827002189034Insemi-FormCOOK INCORPORATEDHDR2016-09-24
10827002164526ShepardCOOK INCORPORATEDHDR2016-09-24
10827002164540ShepardCOOK INCORPORATEDHDR2016-09-24
10827002164588ShepardCOOK INCORPORATEDHDR2016-09-24
10827002164632ShepardCOOK INCORPORATEDHDR2016-09-24
10827002164649ShepardCOOK INCORPORATEDHDR2016-09-24