Blakesley biopsy fcps.insert,5/330mm - Blakesley biopsy fcps.insert,5/330mm - mahe medical gmbh

Duns Number:342243334

Device Description: Blakesley biopsy fcps.insert,5/330mm

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More Product Details

Catalog Number

088.33

Brand Name

Blakesley biopsy fcps.insert,5/330mm

Version/Model Number

088.33

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

MR Safe

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

-

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

950a9801-6451-442e-8036-8221fd711fe8

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 03, 2016

Additional Identifiers

Package DI Number

EMAH088331

Quantity per Package

1

Contains DI Package

EMAH088330

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"MAHE MEDICAL GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 19
2 A medical device with a moderate to high risk that requires special controls. 1976