TRACOE technic® Disposable Inflation Device - Inflation Device Atrion Part Number 96492: 25mL, - ATRION MEDICAL PRODUCTS, INC.

Duns Number:047571476

Device Description: Inflation Device Atrion Part Number 96492: 25mL, 30atm

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More Product Details

Catalog Number

725

Brand Name

TRACOE technic® Disposable Inflation Device

Version/Model Number

QL2530

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

KOE

Product Code Name

Dilator, Urethral

Device Record Status

Public Device Record Key

9ce86f7b-563a-419a-9575-d47257d9caaf

Public Version Date

November 11, 2020

Public Version Number

6

DI Record Publish Date

October 04, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ATRION MEDICAL PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 61