FDA.report

Wallace SurePro Ultra Embryo Replacement Catheter w/ Stylet

Primary DI
30888937021302
Brand
Wallace SurePro Ultra Embryo Replacement Catheter w/ Stylet
Company
Coopersurgical, Inc.
Model
PES623
Device description
Wallace SurePro Ultra Embryo Replacement Catheter w/ Stylet, 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

Related Records

Product Codes

CodeName
MQFCatheter, Assisted Reproduction

Product Code Classifications

CodeDeviceSpecialtyClass
MQFCatheter, Assisted ReproductionObstetrics/Gynecology2

Premarket Submissions

SubmissionSupplement
K990349000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K990349000WALLACE MALLEABLE STYLET-18CM, MODEL 1816ST, WALLACE MALLEABLE STYLET-23CM, MODEL 1816NSTCooperSurgical, Inc.1999-07-26MQF

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20888937021305PackageGS110In Commercial Distribution
30888937021302PackageGS110In Commercial Distribution
00888937021301PrimaryGS10

GMDN Terms

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

TypeValueUnit
Catheter Length23Centimeter

Sterilization Methods

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

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