Duns Number:718296825
Device Description: Box of 200 Sterile Single-Use Lancing Device 30Gauge
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
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
FMK
Product Code Name
Lancet, Blood
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
Package DI Number
20812608030228
Quantity per Package
24
Contains DI Package
00812608030224
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Cardboard box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1 |