Integra® Miltex® - Ragnell Retractor, 6", Double-Ended, 3mm X 8mm - INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Duns Number:081277700

Device Description: Ragnell Retractor, 6", Double-Ended, 3mm X 8mm and 5mm X 15mm Blades, Delicate

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More Product Details

Catalog Number

11-73

Brand Name

Integra® Miltex®

Version/Model Number

11-73

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

GAD

Product Code Name

RETRACTOR

Device Record Status

Public Device Record Key

c2cf4c2a-acf9-4a32-b05f-3cadba8af577

Public Version Date

February 05, 2020

Public Version Number

4

DI Record Publish Date

June 28, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INTEGRA LIFESCIENCES PRODUCTION CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 15051
2 A medical device with a moderate to high risk that requires special controls. 4286
3 A medical device with high risk that requires premarket approval 2
U Unclassified 3