I/A Co-axial Handpiece 45 Degree Angled Tip - I/A Co-axial Handpiece 45 Degree Angled Tip - Surgical Specialties México, S. de R.L. de C.V.

Duns Number:812762226

Device Description: I/A Co-axial Handpiece 45 Degree Angled Tip

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More Product Details

Catalog Number

-

Brand Name

I/A Co-axial Handpiece 45 Degree Angled Tip

Version/Model Number

92-5045

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

HMX

Product Code Name

Cannula, ophthalmic

Device Record Status

Public Device Record Key

eef3a9cb-5578-47ff-a910-08be23feaa28

Public Version Date

October 07, 2019

Public Version Number

6

DI Record Publish Date

June 29, 2017

Additional Identifiers

Package DI Number

10848782023919

Quantity per Package

5

Contains DI Package

00848782023912

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"SURGICAL SPECIALTIES MÉXICO, S. DE R.L. DE C.V." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 300
2 A medical device with a moderate to high risk that requires special controls. 2030
U Unclassified 19