DVT-PRO - Main device 1ea, MULTI-USE THIGH SLEEVE - DAESUNG MAREF CO.,LTD.

Duns Number:688817949

Device Description: Main device 1ea, MULTI-USE THIGH SLEEVE Medium[3CAUF10] 2ea, Tubing(81cm) 2ea [One set box Main device 1ea, MULTI-USE THIGH SLEEVE Medium[3CAUF10] 2ea, Tubing(81cm) 2ea [One set box]

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More Product Details

Catalog Number

-

Brand Name

DVT-PRO

Version/Model Number

DVTP200-MC

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

K203353,K203353

Product Code Details

Product Code

JOW

Product Code Name

Sleeve, Limb, Compressible

Device Record Status

Public Device Record Key

ee262ec4-01ee-46bf-afc5-9c4b65f4aa69

Public Version Date

June 30, 2021

Public Version Number

1

DI Record Publish Date

June 22, 2021

Additional Identifiers

Package DI Number

18809315679852

Quantity per Package

8

Contains DI Package

08809315679855

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"DAESUNG MAREF CO.,LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8
2 A medical device with a moderate to high risk that requires special controls. 175