FDA.reportPublic FDA data

Wallace SurePro Embryo Replacement Catheter w/ Obturator

Primary DI
30888937021265
Brand
Wallace SurePro Embryo Replacement Catheter w/ Obturator
Company
Coopersurgical, Inc.
Model
PPB623
Device description
Wallace SurePro Embryo Replacement Catheter w/ Obturator, Soft 23 cm (Box of 10)
Published
2019-12-04
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
MQFCatheter, Assisted Reproduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQFCatheter, Assisted ReproductionObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888937021268PackageGS110In Commercial Distribution
30888937021265PackageGS110In Commercial Distribution
00888937021264PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088893702126820888937021268
3088893702126530888937021265
00888937021264008889370212648889370212640888937021264

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
Catheter Length23Centimeter

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
60888937029798ORIGIO Gradient 90 w/o Gentamicin 84905060D2026-03-12
00888937028331ORIGIO Sequential Blast83050010M2026-02-05
00888937028348ORIGIO Sequential Blast83050060M2026-02-05
00888937028355ORIGIO Sequential Blast83060010M2026-02-05
00888937028386ORIGIO Sequential Cleav83030010M2026-02-05
00888937028393ORIGIO Sequential Cleav83030060M2026-02-05
00888937028409ORIGIO Sequential Cleav83040010M2026-02-05
00888937028416ORIGIO Sequential Cleav83040060M2026-02-05
00888937028430ORIGIO Sequential Fert83010010M2026-02-05
00888937028447ORIGIO Sequential Fert83010060M2026-02-05
00888937028454ORIGIO Sequential Fert83020010M2026-02-05
00888937028461ORIGIO Sequential Fert83020060M2026-02-05
00888937028607SynVitro Flush15840125M2026-02-05
00888937028959Origio Handling83100060M83102026-02-05
00888937028966Origio Handling83100125M83102026-02-05
00888937028973Origio Handling83110060M83112026-02-05
00888937028980Origio Handling83110125M83112026-02-05
00888937029116SAGE 1-Step67010010M2026-02-05
00888937029123SAGE 1-Step67010060M2026-02-05
60888937029330ORIGIO Sperm Wash84050060M2026-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971855770902Minvitro Embryo Transfer CatheterGuangzhou Hehong Biotech Co., Ltd.MQF2026-03-10
06971855770919Minvitro Embryo Transfer CatheterGuangzhou Hehong Biotech Co., Ltd.MQF2026-03-10
06971855770926Minvitro Embryo Transfer CatheterGuangzhou Hehong Biotech Co., Ltd.MQF2026-03-10
06971855770933Minvitro Embryo Transfer CatheterGuangzhou Hehong Biotech Co., Ltd.MQF2026-03-10
06971855770940Minvitro Embryo Transfer CatheterGuangzhou Hehong Biotech Co., Ltd.MQF2026-03-10
06971855770957Minvitro Embryo Transfer CatheterGuangzhou Hehong Biotech Co., Ltd.MQF2026-03-10
14580745043782ET CATHETER RYDENKITAZATO CORPORATIONMQF2025-09-17
14580745043904ET CATHETER RYDENKITAZATO CORPORATIONMQF2025-09-17
14580745044239ET CATHETER RYDENKITAZATO CORPORATIONMQF2025-09-17
14580745044246ET CATHETER RYDENKITAZATO CORPORATIONMQF2025-09-17
14580745043775ET CatheterKITAZATO CORPORATIONMQF2024-09-09
14580745043898ET CatheterKITAZATO CORPORATIONMQF2024-09-09
14580745044260ET CatheterKITAZATO CORPORATIONMQF2024-09-09
14580745044284ET CatheterKITAZATO CORPORATIONMQF2024-09-09
06971982050328VitaVitroShenzhen Vitavitro Bio-Tech Co.,LtdMQF2024-08-26
06971982050335VitaVitroShenzhen Vitavitro Bio-Tech Co.,LtdMQF2024-08-26
06971982050342VitaVitroShenzhen Vitavitro Bio-Tech Co.,LtdMQF2024-08-26
06971982051066VitaVitroShenzhen Vitavitro Bio-Tech Co.,LtdMQF2024-08-26
06971982051073VitaVitroShenzhen Vitavitro Bio-Tech Co.,LtdMQF2024-08-26
M803TMI1290Embryo Transfer Catheter MEDGYN PRODUCTS, INC.MQF2024-01-03
03700111425026FRYDMAN® CLASSIC 4.5LABORATOIRE CCDMQF2023-12-05
03700111425033FRYDMAN® CLASSIC 5.5LABORATOIRE CCDMQF2023-12-05
03700111425040FRYDMAN ® SOFT WITH GUIDELABORATOIRE CCDMQF2023-12-05
03700111425064T.D.T.®SETLABORATOIRE CCDMQF2023-12-05
03700111425088INVENTCATH ECOLABORATOIRE CCDMQF2023-12-05
03700111425095STYLET FOR FRYDMAN® ULTRASOFT & FRYDMAN® ULTRASOFT echoLABORATOIRE CCDMQF2023-12-05
03700111425101CLASSIC ULTRASOFT 18 CMLABORATOIRE CCDMQF2023-12-05
03700111425125ULTRASOFT FRYDMAN ® SET ECHO WITH GUIDELABORATOIRE CCDMQF2023-12-05
03700111425132MOCK CATHETERLABORATOIRE CCDMQF2023-12-05
03700111425149CLASSIC ULTRASOFT MOCK 18 CMLABORATOIRE CCDMQF2023-12-05