CLARITY RETRACTOR SYSTEM - DOCKING PIN CADDY - Pioneer Surgical Technology, Inc.

Duns Number:793384496

Device Description: DOCKING PIN CADDY

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More Product Details

Catalog Number

38-PIN-CADDY

Brand Name

CLARITY RETRACTOR SYSTEM

Version/Model Number

38-PIN-CADDY

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

LXH

Product Code Name

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Device Record Status

Public Device Record Key

dc8fcd21-9b43-48a3-8901-b1f760be162e

Public Version Date

October 14, 2021

Public Version Number

2

DI Record Publish Date

February 04, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PIONEER SURGICAL TECHNOLOGY, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3116
2 A medical device with a moderate to high risk that requires special controls. 5221