SCANLAN® Needle Holders - LEGACY Jacobson Titanium Micro Needle Holder - SCANLAN INTERNATIONAL INC

Duns Number:023055619

Device Description: LEGACY Jacobson Titanium Micro Needle Holder

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More Product Details

Catalog Number

3003-358

Brand Name

SCANLAN® Needle Holders

Version/Model Number

3003-358

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

FHQ

Product Code Name

Holder, Needle, Gastroenterologic

Device Record Status

Public Device Record Key

3975db50-a405-4585-9d03-b771ca445697

Public Version Date

January 08, 2021

Public Version Number

4

DI Record Publish Date

June 17, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SCANLAN INTERNATIONAL INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1949
2 A medical device with a moderate to high risk that requires special controls. 855