Speedlock - TC Allis, 10mm, Diamond Serration with Ratchet - NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

Duns Number:839138955

Device Description: TC Allis, 10mm, Diamond Serration with Ratchet Handle: D1368 Composite On/Off Ratchet, 30c TC Allis, 10mm, Diamond Serration with Ratchet Handle: D1368 Composite On/Off Ratchet, 30cm Length

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More Product Details

Catalog Number

-

Brand Name

Speedlock

Version/Model Number

8514-89-30-R/D1368

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

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Device Record Status

Public Device Record Key

eda446ce-98e9-45fd-a8b9-e0d301711d1d

Public Version Date

August 21, 2019

Public Version Number

3

DI Record Publish Date

December 13, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NATIONAL ADVANCED ENDOSCOPY DEVICES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 579
2 A medical device with a moderate to high risk that requires special controls. 6418