NA - 2.3 MM FLUTED MATCHSTICK,USE WITH QD8-G1, - Anspach Effort, The

Duns Number:079116867

Device Description: 2.3 MM FLUTED MATCHSTICK,USE WITH QD8-G1, SHORT-G1, QD8, QD8-S, SHORT ATTACHMENTS.

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More Product Details

Catalog Number

S-8N-L-G1

Brand Name

NA

Version/Model Number

S-8N-L-G1

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

Yes

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

K113476

Product Code Details

Product Code

HBE

Product Code Name

DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Device Record Status

Public Device Record Key

3e9f474a-6b3c-4676-9434-d12594da35df

Public Version Date

November 01, 2018

Public Version Number

4

DI Record Publish Date

September 09, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ANSPACH EFFORT, THE" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 294
2 A medical device with a moderate to high risk that requires special controls. 910