SWISS MODEL BLADE BREAKER HOLDER - SWISS MODEL BLADE BREAKER HOLDER SPHERICAL TIP - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: SWISS MODEL BLADE BREAKER HOLDER SPHERICAL TIP

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More Product Details

Catalog Number

11-4850

Brand Name

SWISS MODEL BLADE BREAKER HOLDER

Version/Model Number

11-4850

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

GDZ

Product Code Name

Handle, Scalpel

Device Record Status

Public Device Record Key

aaa94ee6-3020-45d7-9493-4381836ef860

Public Version Date

May 08, 2019

Public Version Number

2

DI Record Publish Date

September 19, 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