AEBLI CORNEAL SCISSORS - AEBLI CORNEAL SCISSORS RIGHT ANGLED BLADE - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: AEBLI CORNEAL SCISSORS RIGHT ANGLED BLADE

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More Product Details

Catalog Number

13-7030

Brand Name

AEBLI CORNEAL SCISSORS

Version/Model Number

13-7030

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

HNF

Product Code Name

Scissors, Ophthalmic

Device Record Status

Public Device Record Key

c273b723-ae5a-431a-975a-7f4acb4fa4b7

Public Version Date

July 08, 2019

Public Version Number

1

DI Record Publish Date

June 28, 2019

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