Stainless Steel Retainer Wire - .045 14' SS RETAINER WIRE (10) - Ortho Arch Company Inc

Duns Number:020956330

Device Description: .045 14' SS RETAINER WIRE (10)

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More Product Details

Catalog Number

270-245

Brand Name

Stainless Steel Retainer Wire

Version/Model Number

270-245

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

DZC

Product Code Name

Wire, Orthodontic

Device Record Status

Public Device Record Key

a92c3b3d-4360-41ec-b1a0-ad620c9bb6d0

Public Version Date

February 10, 2022

Public Version Number

1

DI Record Publish Date

February 02, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ORTHO ARCH COMPANY INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1814
2 A medical device with a moderate to high risk that requires special controls. 130