Ambler Surgical - Inge lamina self-retaining spreader, 9 1/2", with - AMBLER SURGICAL CORP.

Duns Number:015272206

Device Description: Inge lamina self-retaining spreader, 9 1/2", with teeth, 64.0mm jaw opening

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

45-219

Brand Name

Ambler Surgical

Version/Model Number

45-219

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

K071771

Product Code Details

Product Code

GZT

Product Code Name

RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY

Device Record Status

Public Device Record Key

53c845d8-a311-43bc-9076-b29beda6fb2e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 29, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AMBLER SURGICAL CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 14984
2 A medical device with a moderate to high risk that requires special controls. 3118