MSP - MINDE KNIFE 1.3MM ANG 10PK - Surgical Specialties México, S. de R.L. de C.V.

Duns Number:812762226

Device Description: MINDE KNIFE 1.3MM ANG 10PK

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More Product Details

Catalog Number

61-130-45A

Brand Name

MSP

Version/Model Number

61-130-45A

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

HNN

Product Code Name

Knife, ophthalmic

Device Record Status

Public Device Record Key

afef7807-1eb2-4c3e-9202-ecd87cdd9b06

Public Version Date

August 31, 2021

Public Version Number

1

DI Record Publish Date

August 23, 2021

Additional Identifiers

Package DI Number

10848782044839

Quantity per Package

10

Contains DI Package

00848782044832

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