Alpha-Tec Systems - NAC-PAC EA3 (3.0%) tray w/ NALC tablets - Alpha-TEC Systems, Inc.

Duns Number:103105524

Device Description: NAC-PAC EA3 (3.0%) tray w/ NALC tablets

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More Product Details

Catalog Number

-

Brand Name

Alpha-Tec Systems

Version/Model Number

0

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

K881698

Product Code Details

Product Code

JSK

Product Code Name

Supplement, Culture Media

Device Record Status

Public Device Record Key

0e70a827-6be8-4ff9-9ab2-a164f25c8347

Public Version Date

August 19, 2022

Public Version Number

1

DI Record Publish Date

August 11, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ALPHA-TEC SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 268