Carbon Steel Surgical Blade - Carbon Steel Surgical Blade,24#,100pcs/box - Sterilance Medical (Suzhou) Inc.

Duns Number:554434897

Device Description: Carbon Steel Surgical Blade,24#,100pcs/box

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More Product Details

Catalog Number

-

Brand Name

Carbon Steel Surgical Blade

Version/Model Number

24#

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

GES

Product Code Name

Blade, Scalpel

Device Record Status

Public Device Record Key

4d12dbc0-6e2f-47f7-b0b4-c87f541c703b

Public Version Date

April 28, 2021

Public Version Number

1

DI Record Publish Date

April 20, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STERILANCE MEDICAL (SUZHOU) INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 11
2 A medical device with a moderate to high risk that requires special controls. 10