Preat - Preci-Sagix 2.2 Noprax Cast-to Male (2-Pack) - Implants and Attachments, Inc.

Duns Number:054875224

Device Description: Preci-Sagix 2.2 Noprax Cast-to Male (2-Pack)

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More Product Details

Catalog Number

0101372-2

Brand Name

Preat

Version/Model Number

0101372-2

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)

Yes

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

EGG

Product Code Name

ATTACHMENT, PRECISION, ALL

Device Record Status

Public Device Record Key

a8bf2b7f-a7ab-42f6-b6a9-e7e6e12f188f

Public Version Date

November 01, 2022

Public Version Number

1

DI Record Publish Date

October 24, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"IMPLANTS AND ATTACHMENTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 958
2 A medical device with a moderate to high risk that requires special controls. 1846