CALICO - Silicone Bordered Foam Dressing Sacral Large - Calico Medical Group LLC

Duns Number:118744421

Device Description: Silicone Bordered Foam Dressing Sacral Large

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More Product Details

Catalog Number

FD017

Brand Name

CALICO

Version/Model Number

FD017

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

-

Product Code Details

Product Code

NAD

Product Code Name

Dressing, Wound, Occlusive

Device Record Status

Public Device Record Key

b132a4db-5584-421b-b7e5-b98a636e8258

Public Version Date

August 30, 2022

Public Version Number

1

DI Record Publish Date

August 22, 2022

Additional Identifiers

Package DI Number

20850044458411

Quantity per Package

20

Contains DI Package

00850044458417

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"CALICO MEDICAL GROUP LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5
2 A medical device with a moderate to high risk that requires special controls. 4
U Unclassified 1