Nasal Hook - Nasal Hook With Twisted Loop - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: Nasal Hook With Twisted Loop

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More Product Details

Catalog Number

-

Brand Name

Nasal Hook

Version/Model Number

467-449

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

-

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

JYL

Product Code Name

HOOK, MICROSURGICAL EAR

Device Record Status

Public Device Record Key

a78d9f48-657d-4475-83d9-96e54a757024

Public Version Date

October 24, 2022

Public Version Number

1

DI Record Publish Date

October 14, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SONTEC INSTRUMENTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10108
2 A medical device with a moderate to high risk that requires special controls. 3414