BABY LEXER-STRABISMUS SCISSORS - BABY LEXER-STRABISMUS SCSSORS STRAIGHT BLADE - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: BABY LEXER-STRABISMUS SCSSORS STRAIGHT BLADE LARGE RING

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More Product Details

Catalog Number

13-9301

Brand Name

BABY LEXER-STRABISMUS SCISSORS

Version/Model Number

13-9301

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

-

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

HNF

Product Code Name

SCISSORS, OPHTHALMIC

Device Record Status

Public Device Record Key

231f4d15-ff5e-4721-b5a0-cebe4b53d14a

Public Version Date

November 26, 2018

Public Version Number

1

DI Record Publish Date

October 24, 2018

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