Vector - 13mm long, 3.0mm diameter Cannulated Hammertoe - NVISION BIOMEDICAL TECHNOLOGIES, INC.

Duns Number:047486041

Device Description: 13mm long, 3.0mm diameter Cannulated Hammertoe Implant (Steam). The Vector Hammertoe Corr

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More Product Details

Catalog Number

-

Brand Name

Vector

Version/Model Number

HAM-13-30C

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

K201850,K213421

Product Code Details

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Device Record Status

Public Device Record Key

ba777a35-7364-4d5c-935b-cca2951308d4

Public Version Date

February 02, 2022

Public Version Number

3

DI Record Publish Date

January 17, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NVISION BIOMEDICAL TECHNOLOGIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 461
2 A medical device with a moderate to high risk that requires special controls. 1046