Duns Number:051957769
Device Description: STERILE, SINGLE-USE SAFETY LANCETS FOR CAPILLARY BLOOD SAMPLING
Catalog Number
8601
Brand Name
ReliOn safety lancet
Version/Model Number
30G 1.5mm
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"
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
FMK
Product Code Name
Lancet, Blood
Public Device Record Key
5124356e-c7bb-4a1f-a205-2aae1bf3a673
Public Version Date
November 11, 2019
Public Version Number
1
DI Record Publish Date
November 01, 2019
Package DI Number
01681131133479
Quantity per Package
20
Contains DI Package
00681131133470
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 76 |