ACU-GUARD - Acu-Guard II easy fit disposable clear sheaths - ACUDERM, INC.

Duns Number:071426803

Device Description: Acu-Guard II easy fit disposable clear sheaths sterile

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More Product Details

Catalog Number

-

Brand Name

ACU-GUARD

Version/Model Number

0ADG51S

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

K915000

Product Code Details

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Device Record Status

Public Device Record Key

c7cdfc4e-85dd-4c5d-af02-dc9330fde187

Public Version Date

February 06, 2020

Public Version Number

2

DI Record Publish Date

January 03, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ACUDERM, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 11
2 A medical device with a moderate to high risk that requires special controls. 61