MICASEPT TOP DUR NEEDLE HOLDER - MICASEPT TOP DUR NEEDLE HOLDER WITH FOLDING - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: MICASEPT TOP DUR NEEDLE HOLDER WITH FOLDING RATCHET CURVED SHORT WIDE JAW

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More Product Details

Catalog Number

20918-08-005

Brand Name

MICASEPT TOP DUR NEEDLE HOLDER

Version/Model Number

20918-08-005

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

K002877

Product Code Details

Product Code

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Device Record Status

Public Device Record Key

c5526e4a-d2a2-4d12-b328-8d3790f787fe

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

August 15, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SONTEC INSTRUMENTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10108
2 A medical device with a moderate to high risk that requires special controls. 3414