SPIDER SCREW - SPIDER SELF- LIGATING K2 Ø 1,9x6 - H.D.C. SRL

Duns Number:339583417

Device Description: SPIDER SELF- LIGATING K2 Ø 1,9x6

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More Product Details

Catalog Number

SXL-1906

Brand Name

SPIDER SCREW

Version/Model Number

SXL-1906

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K091390

Product Code Details

Product Code

OAT

Product Code Name

Implant, Endosseous, Orthodontic

Device Record Status

Public Device Record Key

8e18c899-448d-4988-89c1-ef32d8591e79

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"H.D.C. SRL" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 29