Ambler Surgical - Allis atraumatic grasping forceps, non-rotatable, - AMBLER SURGICAL CORP.

Duns Number:015272206

Device Description: Allis atraumatic grasping forceps, non-rotatable, double-action, 5.0mm diameter, 350.0mm w Allis atraumatic grasping forceps, non-rotatable, double-action, 5.0mm diameter, 350.0mm working length, insulated shaft, straight tips, fine serrated jaws, interlocking teeth, ring handle with ratchet catch

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More Product Details

Catalog Number

97-010

Brand Name

Ambler Surgical

Version/Model Number

Allis atraumatic grasping forceps

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

K040855

Product Code Details

Product Code

GEI

Product Code Name

Electrosurgical, cutting & coagulation & accessories

Device Record Status

Public Device Record Key

29be3a91-4a8a-4c09-82ca-5268467f6425

Public Version Date

January 12, 2021

Public Version Number

1

DI Record Publish Date

January 04, 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