Disc Prep - Pituitary-10 IN. Toothed 3mm - SEASPINE ORTHOPEDICS CORPORATION

Duns Number:079840876

Device Description: Pituitary-10 IN. Toothed 3mm

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More Product Details

Catalog Number

06-35-0203

Brand Name

Disc Prep

Version/Model Number

06-35-0203

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

-

Product Code Details

Product Code

HTX

Product Code Name

RONGEUR

Device Record Status

Public Device Record Key

519dd340-4d32-4f9e-aad2-84677d8d9eaa

Public Version Date

July 12, 2019

Public Version Number

3

DI Record Publish Date

May 02, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SEASPINE ORTHOPEDICS CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5602
2 A medical device with a moderate to high risk that requires special controls. 14020
U Unclassified 21