Ambler Surgical - Breisky vaginal retractor, 14 3/8'', 180.0mm long - AMBLER SURGICAL CORP.

Duns Number:015272206

Device Description: Breisky vaginal retractor, 14 3/8'', 180.0mm long x 35.0mm wide blade, round handle

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More Product Details

Catalog Number

70-878

Brand Name

Ambler Surgical

Version/Model Number

Breisky vaginal retractor

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

HDL

Product Code Name

RETRACTOR, VAGINAL

Device Record Status

Public Device Record Key

9d670553-9abb-48e7-8b2a-43c6de64a360

Public Version Date

January 15, 2021

Public Version Number

1

DI Record Publish Date

January 07, 2021

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