Wallace Embryo Replacement Catheter

GUDID 30888937021197

Wallace Embryo Replacement Catheter, Soft 18cm (Box of 10)

Coopersurgical, Inc.

Assisted reproduction transfer catheter/set
Primary Device ID30888937021197
NIH Device Record Keyb9a45a10-c07c-4b3b-ab8d-d42272927e4e
Commercial Distribution StatusIn Commercial Distribution
Brand NameWallace Embryo Replacement Catheter
Version Model Number1816
Company DUNS801895244
Company NameCoopersurgical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Catheter Length18 Centimeter
Catheter Length18 Centimeter
Catheter Length18 Centimeter
Catheter Length18 Centimeter
Catheter Length18 Centimeter
Catheter Length18 Centimeter
Catheter Length18 Centimeter
Catheter Length18 Centimeter
Catheter Length18 Centimeter
Catheter Length18 Centimeter
Catheter Length18 Centimeter
Catheter Length18 Centimeter
Catheter Length18 Centimeter
Catheter Length18 Centimeter
Catheter Length18 Centimeter
Catheter Length18 Centimeter
Catheter Length18 Centimeter
Catheter Length18 Centimeter
Catheter Length18 Centimeter
Catheter Length18 Centimeter
Catheter Length18 Centimeter
Catheter Length18 Centimeter
Catheter Length18 Centimeter
Catheter Length18 Centimeter
Catheter Length18 Centimeter
Catheter Length18 Centimeter
Catheter Length18 Centimeter
Catheter Length18 Centimeter
Catheter Length18 Centimeter
Catheter Length18 Centimeter
Catheter Length18 Centimeter
Catheter Length18 Centimeter
Catheter Length18 Centimeter
Catheter Length18 Centimeter
Catheter Length18 Centimeter
Catheter Length18 Centimeter
Catheter Length18 Centimeter
Catheter Length18 Centimeter
Catheter Length18 Centimeter
Catheter Length18 Centimeter
Catheter Length18 Centimeter
Catheter Length18 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100888937021196 [Primary]
GS120888937021190 [Package]
Contains: 00888937021196
Package: Box [10 Units]
In Commercial Distribution
GS130888937021197 [Package]
Contains: 20888937021190
Package: Case [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQFCatheter, Assisted Reproduction

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-12
Device Publish Date2019-12-04

On-Brand Devices [Wallace Embryo Replacement Catheter]

30888937021227Wallace Embryo Replacement Catheter, Intermediate 23 cm (Box of 10)
30888937021210Wallace Embryo Replacement Catheter, Intermediate 18 cm (Box of 10)
30888937021203Wallace Embryo Replacement Catheter, Soft 23 cm (Box of 10)
30888937021197Wallace Embryo Replacement Catheter, Soft 18cm (Box of 10)

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