Oxboro ™ Specialty Tip Protectors - Designed to protect medical instruments from - ASPEN SURGICAL PRODUCTS, INC.

Duns Number:027680821

Device Description: Designed to protect medical instruments from damage during sterilization, storage, and han Designed to protect medical instruments from damage during sterilization, storage, and handling

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More Product Details

Catalog Number

-

Brand Name

Oxboro ™ Specialty Tip Protectors

Version/Model Number

096013BBG

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

-

Product Code Details

Product Code

MDM

Product Code Name

INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Device Record Status

Public Device Record Key

f39c1005-a64f-4140-80da-b58f482c999f

Public Version Date

April 01, 2022

Public Version Number

2

DI Record Publish Date

February 25, 2021

Additional Identifiers

Package DI Number

00840113226177

Quantity per Package

50

Contains DI Package

00840113226153

Package Discontinue Date

September 14, 2021

Package Status

Not in Commercial Distribution

Package Type

-

"ASPEN SURGICAL PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 952
2 A medical device with a moderate to high risk that requires special controls. 494