Batrik Bitestrong’/20mm/Adult/no dental retention rim/Single - BitestrongTM Bite Block, Blue, 20 mm, single use - Batrik Medical Manufacturing Inc

Duns Number:243880700

Device Description: BitestrongTM Bite Block, Blue, 20 mm, single use

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More Product Details

Catalog Number

B3-NDR

Brand Name

Batrik Bitestrong’/20mm/Adult/no dental retention rim/Single

Version/Model Number

B3-NDR

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"

Yes

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

f8ede504-3105-4666-9b40-38ac725c6649

Public Version Date

November 08, 2021

Public Version Number

1

DI Record Publish Date

October 29, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BATRIK MEDICAL MANUFACTURING INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 748
2 A medical device with a moderate to high risk that requires special controls. 20