Aspire - Custom ITCD 96 - HEARING LAB TECHNOLOGY, LLC

Duns Number:827693503

Device Description: Custom ITCD 96

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More Product Details

Catalog Number

HLT-AHICUSITCD-96

Brand Name

Aspire

Version/Model Number

ITCD 96

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

ESD

Product Code Name

Hearing aid, air conduction

Device Record Status

Public Device Record Key

4c8b2a2b-f04a-4c91-92a2-238cacd70c1e

Public Version Date

October 06, 2020

Public Version Number

2

DI Record Publish Date

May 20, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HEARING LAB TECHNOLOGY, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 138
2 A medical device with a moderate to high risk that requires special controls. 352