Autoclavable Plastic Sterilisation Tray with mat, small - Autoclavable Plastic Sterilisation Tray with mat, - Oculo-Plastik Inc

Duns Number:257382580

Device Description: Autoclavable Plastic Sterilisation Tray with mat, small

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More Product Details

Catalog Number

-

Brand Name

Autoclavable Plastic Sterilisation Tray with mat, small

Version/Model Number

27-6530

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 24, 2022

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FSM

Product Code Name

Tray, Surgical, Instrument

Device Record Status

Public Device Record Key

ecf6cb28-88f1-4651-8b3d-c9e04420ace0

Public Version Date

March 25, 2022

Public Version Number

3

DI Record Publish Date

November 07, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OCULO-PLASTIK INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 192
2 A medical device with a moderate to high risk that requires special controls. 88