Key Surgical Bite Blocks - Bite Block, 21mm scope port, adult bite block - KEY SURGICAL, INC.

Duns Number:604056226

Device Description: Bite Block, 21mm scope port, adult bite block with pliable strap

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More Product Details

Catalog Number

-

Brand Name

Key Surgical Bite Blocks

Version/Model Number

EN-310

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

Yes

Prescription Use (Rx)

-

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

MNK

Product Code Name

Endoscopic Bite Block

Device Record Status

Public Device Record Key

7038e626-8150-438e-89cb-a26efb48db66

Public Version Date

September 08, 2021

Public Version Number

3

DI Record Publish Date

December 09, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KEY SURGICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 326
2 A medical device with a moderate to high risk that requires special controls. 219