SNAP™ - Snap Therapy System Snap 100mmHg Therapy - KCI USA, INC.

Duns Number:102726734

Device Description: Snap Therapy System Snap 100mmHg Therapy Cartridge 60ml

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More Product Details

Catalog Number

-

Brand Name

SNAP™

Version/Model Number

SNPA100US

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K112341,K112341,K112341

Product Code Details

Product Code

OKO

Product Code Name

Negative Pressure Wound Therapy Non-Powered Suction Apparatus

Device Record Status

Public Device Record Key

2ac9b4e7-42e5-4669-a875-98f071c97e59

Public Version Date

September 09, 2020

Public Version Number

7

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

20849554006045

Quantity per Package

10

Contains DI Package

00849554006041

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

10 PACK

"KCI USA, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 63