SafetiCet - A sterile and single use device, hand-held manual - NSP TECH PTE LTD

Duns Number:653632729

Device Description: A sterile and single use device, hand-held manual instrument intended to be used for contr A sterile and single use device, hand-held manual instrument intended to be used for controlled skin puncture/cut to obtain a capillary blood specimen, performed by a healthcare provider or a patient (e.g., a diabetic), typically at the fingertip. It includes a preloaded lancet tip, and has a manually-powered mechanism (e.g., spring-loaded) which enables the tip to puncture to a predetermined depth and blood subsequently to be squeezed out of the puncture site

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More Product Details

Catalog Number

SC-150-010

Brand Name

SafetiCet

Version/Model Number

SC-150

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

April 30, 2026

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)

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

9ea7e1f1-ec78-45cf-9e99-55abd878638e

Public Version Date

May 10, 2021

Public Version Number

1

DI Record Publish Date

April 30, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NSP TECH PTE LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1