Catalog Number

UL7051-16

Brand Name

Self-retaining retractor acc. to Weitlan 3x4 prongs blunt L=160mm

Version/Model Number

UL7051-16

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

Yes

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

GZT

Product Code Name

RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY

Public Device Record Key

83eed742-9492-4bd5-b060-7b871b7ed87f

Public Version Date

November 19, 2018

Public Version Number

1

DI Record Publish Date

October 18, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-