Wallace Artificial Insemination Catheter

Primary DI
30888937021333
Brand
Wallace Artificial Insemination Catheter
Company
Coopersurgical, Inc.
Model
AIC18
Device description
Artificial insemination catheter, 18cm
Published
2019-09-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K964848000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K964848000WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CMMarlow Surgical Technologies, Inc.1997-01-16MFD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888937021336PackageGS110In Commercial Distribution
30888937021333PackageGS110In Commercial Distribution
00888937021332PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088893702133620888937021336
3088893702133330888937021333
00888937021332008889370213328889370213320888937021332

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
Length10Centimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
801895244
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
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
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