HI-FI - Hi-Fi Blue Size 2 40" HS40 Needle ConMed - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: Hi-Fi Blue Size 2 40" HS40 Needle ConMed

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More Product Details

Catalog Number

H6140RC

Brand Name

HI-FI

Version/Model Number

IPN001169

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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)

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

GAT

Product Code Name

SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Device Record Status

Public Device Record Key

c405983e-e328-4541-842f-8995792b07aa

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

January 17, 2019

Additional Identifiers

Package DI Number

44026704604096

Quantity per Package

12

Contains DI Package

34026704604099

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"TELEFLEX INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3195
2 A medical device with a moderate to high risk that requires special controls. 13747
3 A medical device with high risk that requires premarket approval 3
U Unclassified 26