Jigsaw Medical, LLC - Endoscopic Retrograde Knife - JIGSAW MEDICAL, LLC

Duns Number:079233827

Device Description: Endoscopic Retrograde Knife

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More Product Details

Catalog Number

50118-S

Brand Name

Jigsaw Medical, LLC

Version/Model Number

50118-S

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"

Yes

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

NBH

Product Code Name

Accessories, Arthroscopic

Device Record Status

Public Device Record Key

88e9a95b-e441-4729-9772-3565769e5d5f

Public Version Date

February 06, 2020

Public Version Number

2

DI Record Publish Date

September 19, 2019

Additional Identifiers

Package DI Number

00856274008262

Quantity per Package

6

Contains DI Package

00856274008101

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"JIGSAW MEDICAL, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 23