Stab Straight - Stab Straight - Surgical Specialties México, S. de R.L. de C.V.

Duns Number:812762226

Device Description: Stab Straight

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More Product Details

Catalog Number

82-3001G

Brand Name

Stab Straight

Version/Model Number

82-3001G

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

2b11cb0d-5b7d-4754-ba70-70814c552e17

Public Version Date

February 07, 2020

Public Version Number

1

DI Record Publish Date

January 30, 2020

Additional Identifiers

Package DI Number

10848782029911

Quantity per Package

5

Contains DI Package

00848782029914

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