IMS - Keyhole Bracket, hole opening 19mm (.750"), - AVALIGN TECHNOLOGIES, INC.

Duns Number:792528510

Device Description: Keyhole Bracket, hole opening 19mm (.750"), silicone height 38.1mm (1.5"), OL 39.37mm (1.5 Keyhole Bracket, hole opening 19mm (.750"), silicone height 38.1mm (1.5"), OL 39.37mm (1.55")

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More Product Details

Catalog Number

-

Brand Name

IMS

Version/Model Number

95-2000162011

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

-

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

KCT

Product Code Name

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Device Record Status

Public Device Record Key

eaa19b20-4b61-4297-ac7f-7a53dc6c9a40

Public Version Date

July 08, 2021

Public Version Number

2

DI Record Publish Date

January 22, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AVALIGN TECHNOLOGIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6832
2 A medical device with a moderate to high risk that requires special controls. 9482