Ssc Bone Wax - Ssc Bone Wax - Surgical Specialties México, S. de R.L. de C.V.

Duns Number:812762226

Device Description: Ssc Bone Wax

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More Product Details

Catalog Number

-

Brand Name

Ssc Bone Wax

Version/Model Number

901

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K791495,K791495

Product Code Details

Product Code

MTJ

Product Code Name

WAX,BONE

Device Record Status

Public Device Record Key

d58f099b-7a58-4ad3-8ee7-517a84cab8d1

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 20, 2015

Additional Identifiers

Package DI Number

10848782008244

Quantity per Package

12

Contains DI Package

00848782008247

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"SURGICAL SPECIALTIES MÉXICO, S. DE R.L. DE C.V." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 300
2 A medical device with a moderate to high risk that requires special controls. 2030
U Unclassified 19