BEAR - Rigid ENT Endoscope, 2.7 x 140mm, 0 Deg. - Bear-Ent, LLC

Duns Number:123551586

Device Description: Rigid ENT Endoscope, 2.7 x 140mm, 0 Deg.

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More Product Details

Catalog Number

BV2700

Brand Name

BEAR

Version/Model Number

BV2700

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K981751

Product Code Details

Product Code

EOB

Product Code Name

Nasopharyngoscope (Flexible Or Rigid)

Device Record Status

Public Device Record Key

fa1881dd-b086-4505-8073-c7fd8fa60a63

Public Version Date

April 04, 2022

Public Version Number

3

DI Record Publish Date

March 03, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BEAR-ENT, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 524
2 A medical device with a moderate to high risk that requires special controls. 21