Needle Adapter - ADAPTER, FOR DENTAL NEEDLE, 3/32in X 1 1/8in LONG - DERMATOLOGIC LAB AND SUPPLY, INC.

Duns Number:021628771

Device Description: ADAPTER, FOR DENTAL NEEDLE, 3/32in X 1 1/8in LONG SHAFT

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More Product Details

Catalog Number

ADAPT/DNTL

Brand Name

Needle Adapter

Version/Model Number

ADAPT/DNTL

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

K001029

Product Code Details

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Device Record Status

Public Device Record Key

d4dda2f0-392f-4eef-95f0-3e861c981134

Public Version Date

August 29, 2018

Public Version Number

2

DI Record Publish Date

July 10, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DERMATOLOGIC LAB AND SUPPLY, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 90