Snowden-Pencer - ERGONOMIC MODULAR TENACULUM GRASPER D/A 5MM, 45CM - CAREFUSION 2200, INC

Duns Number:832696038

Device Description: ERGONOMIC MODULAR TENACULUM GRASPER D/A 5MM, 45CM INSERT ESU

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More Product Details

Catalog Number

SP8455

Brand Name

Snowden-Pencer

Version/Model Number

SP8455

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"

-

For Single-Use

-

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

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Device Record Status

Public Device Record Key

53211591-6867-477d-afea-7082810b32f6

Public Version Date

January 28, 2021

Public Version Number

2

DI Record Publish Date

December 03, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CAREFUSION 2200, INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8016
2 A medical device with a moderate to high risk that requires special controls. 6223