Sphere™ Inflation Device - Inflation Device Atrion Part Number 96469A: 20mL, - ATRION MEDICAL PRODUCTS, INC.

Duns Number:047571476

Device Description: Inflation Device Atrion Part Number 96469A: 20mL, 30atm

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More Product Details

Catalog Number

CID-20-30-NG

Brand Name

Sphere™ Inflation Device

Version/Model Number

QL2030PR

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

464b06c5-3624-4ea6-8f30-c28e619706da

Public Version Date

January 08, 2021

Public Version Number

6

DI Record Publish Date

September 21, 2016

Additional Identifiers

Package DI Number

10827002255712

Quantity per Package

1

Contains DI Package

00827002255715

Package Discontinue Date

-

Package Status

In Commercial Distribution

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