Wallace SurePro Ultra Embryo Replacement Catheter w/ Obturator - Wallace SurePro Ultra Embryo Replacement Catheter - Coopersurgical, Inc.

Duns Number:801895244

Device Description: Wallace SurePro Ultra Embryo Replacement Catheter w/ Obturator, Soft 23 cm (Box of 10)

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More Product Details

Catalog Number

-

Brand Name

Wallace SurePro Ultra Embryo Replacement Catheter w/ Obturator

Version/Model Number

PEB623

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

MQF

Product Code Name

Catheter, Assisted Reproduction

Device Record Status

Public Device Record Key

b7b9caec-47b4-4f42-bba5-baaa3d300652

Public Version Date

September 07, 2020

Public Version Number

2

DI Record Publish Date

December 04, 2019

Additional Identifiers

Package DI Number

30888937021296

Quantity per Package

10

Contains DI Package

20888937021299

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"COOPERSURGICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 29
2 A medical device with a moderate to high risk that requires special controls. 1471
3 A medical device with high risk that requires premarket approval 2