5mm Andrew Babcock Forcep, Ratcheting Handle, With Rotation - ENCISION, INC.

Duns Number:612250175

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More Product Details

Catalog Number

EP3770RR

Brand Name

5mm Andrew Babcock Forcep, Ratcheting Handle, With Rotation

Version/Model Number

EP3770RR

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

K925079

Product Code Details

Product Code

HET

Product Code Name

Laparoscope, Gynecologic (And Accessories)

Device Record Status

Public Device Record Key

e5e53c3f-2c1b-48b0-a121-8f562efc3e9a

Public Version Date

August 21, 2019

Public Version Number

4

DI Record Publish Date

August 31, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ENCISION, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 208