MST/Packard Gold Silicone Sleeve for 1.8-2.2 incision - MICROSURGICAL TECHNOLOGY, INC.

Duns Number:097824130

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More Product Details

Catalog Number

SIL-0004-G

Brand Name

MST/Packard Gold Silicone Sleeve for 1.8-2.2 incision

Version/Model Number

SIL-0004-G

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)

-

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

KYG

Product Code Name

Device, Irrigation, Ocular Surgery

Device Record Status

Public Device Record Key

da8dc00c-093f-4da4-adfe-cf344a0913a9

Public Version Date

October 07, 2019

Public Version Number

4

DI Record Publish Date

September 19, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MICROSURGICAL TECHNOLOGY, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 327
2 A medical device with a moderate to high risk that requires special controls. 535