Slit Knife Full Hdl-2.2MM ANG - Slit Knife Full Hdl-2.2MM ANG - Surgical Specialties México, S. de R.L. de C.V.

Duns Number:812762226

Device Description: Slit Knife Full Hdl-2.2MM ANG

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

82-2261G

Brand Name

Slit Knife Full Hdl-2.2MM ANG

Version/Model Number

82-2261G

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

K822112,K822112

Product Code Details

Product Code

HNN

Product Code Name

Knife, ophthalmic

Device Record Status

Public Device Record Key

d4bca727-885c-4e26-804d-420e0d8be78b

Public Version Date

February 07, 2020

Public Version Number

1

DI Record Publish Date

January 30, 2020

Additional Identifiers

Package DI Number

10848782004833

Quantity per Package

5

Contains DI Package

00848782004836

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