11mm Conical Tap - 11mm Conical Tap - SYMMETRY MEDICAL INC.

Duns Number:079881212

Device Description: 11mm Conical Tap

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More Product Details

Catalog Number

2709-01-013;00-9986-010-24;430033

Brand Name

11mm Conical Tap

Version/Model Number

12-009-000

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

HWX

Product Code Name

Tap, Bone

Device Record Status

Public Device Record Key

1b36b4fa-d183-4406-82e5-6daecbfcb614

Public Version Date

May 18, 2022

Public Version Number

1

DI Record Publish Date

May 10, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SYMMETRY MEDICAL INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 201
2 A medical device with a moderate to high risk that requires special controls. 35