EXMOOR - Silicone rubber sheet - EXMOOR PLASTICS LIMITED

Duns Number:298725490

Device Description: Silicone rubber sheet

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

SRS6A(29)

Brand Name

EXMOOR

Version/Model Number

SRS.6a(29)

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K911503,K911503

Product Code Details

Product Code

KHJ

Product Code Name

Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)

Device Record Status

Public Device Record Key

5620bcda-a2f1-49a7-84ba-75581813363a

Public Version Date

October 15, 2019

Public Version Number

2

DI Record Publish Date

September 21, 2018

Additional Identifiers

Package DI Number

05060180254612

Quantity per Package

20

Contains DI Package

05060180252106

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

a box

"EXMOOR PLASTICS LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 245
2 A medical device with a moderate to high risk that requires special controls. 43