Instrument - Common Lid - Transparent - Stanmore Implants Worldwide Ltd

Duns Number:494989502

Device Description: Common Lid - Transparent

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More Product Details

Catalog Number

LID

Brand Name

Instrument

Version/Model Number

LID-SIW

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

-

Product Code Details

Product Code

FSM

Product Code Name

Tray, Surgical, Instrument

Device Record Status

Public Device Record Key

f0b4c964-f2d8-4942-85ab-a1f912357b3b

Public Version Date

September 16, 2022

Public Version Number

6

DI Record Publish Date

July 18, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STANMORE IMPLANTS WORLDWIDE LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 17
2 A medical device with a moderate to high risk that requires special controls. 78