Speedlock - Babcock, Short Version for Delicate Applications, - NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

Duns Number:839138955

Device Description: Babcock, Short Version for Delicate Applications, 5mm with Ratchet Handle: 8511-01 Standar Babcock, Short Version for Delicate Applications, 5mm with Ratchet Handle: 8511-01 Standard Composite, 30cm Length

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


More Product Details

Catalog Number

-

Brand Name

Speedlock

Version/Model Number

8515-09-30-R/8511-01

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

13cea6cb-88fa-439f-85b9-38009a206ca1

Public Version Date

August 21, 2019

Public Version Number

3

DI Record Publish Date

December 16, 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