Ambler Surgical - Iris non-stick bipolar forceps, 4", angled, 0.4mm - AMBLER SURGICAL CORP.

Duns Number:015272206

Device Description: Iris non-stick bipolar forceps, 4", angled, 0.4mm tips, insulated, provided individually s Iris non-stick bipolar forceps, 4", angled, 0.4mm tips, insulated, provided individually sterile, single-use, disposable, box of 10

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More Product Details

Catalog Number

FD2025

Brand Name

Ambler Surgical

Version/Model Number

FD2025

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K900533

Product Code Details

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Device Record Status

Public Device Record Key

55504ac2-dc26-4782-996c-8d8b30690ce5

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 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