OneTouch Delica Safety - Box of 200 Sterile Single-Use Lancing Device - ASAHI POLYSLIDER COMPANY,LIMITED

Duns Number:718296825

Device Description: Box of 200 Sterile Single-Use Lancing Device 30Gauge

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More Product Details

Catalog Number

OTD Safety 30g US/CA/LATAM 200

Brand Name

OneTouch Delica Safety

Version/Model Number

024-206

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FMK

Product Code Name

Lancet, Blood

Device Record Status

Public Device Record Key

3efdd12c-01f5-4d0f-b784-090d640a1e6f

Public Version Date

March 08, 2021

Public Version Number

1

DI Record Publish Date

February 26, 2021

Additional Identifiers

Package DI Number

20812608030228

Quantity per Package

24

Contains DI Package

00812608030224

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Cardboard box

"ASAHI POLYSLIDER COMPANY,LIMITED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1