Velclose - STERILE VELCLOSE ELASTIC BANDAGE, 3IN - TETRA MEDICAL SUPPLY CORP.

Duns Number:047580212

Device Description: STERILE VELCLOSE ELASTIC BANDAGE, 3IN

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More Product Details

Catalog Number

S630-LF

Brand Name

Velclose

Version/Model Number

S630-LF

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

FQM

Product Code Name

Bandage, Elastic

Device Record Status

Public Device Record Key

72f9e2be-b8d7-4039-afdf-0d1ae3dd383c

Public Version Date

August 16, 2022

Public Version Number

1

DI Record Publish Date

August 08, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TETRA MEDICAL SUPPLY CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 486