Duns Number:043081723
Device Description: Advocate Lancets Safety 28 Gauge 1.8 mm box of 200, sterile, for capillary blood sample, n Advocate Lancets Safety 28 Gauge 1.8 mm box of 200, sterile, for capillary blood sample, needle automatically retracts, ready to use, no loading needed, single use only
Catalog Number
-
Brand Name
Advocate Lancets Safety 28 Gauge
Version/Model Number
637
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
4957dfe1-a804-42b9-a591-cd249b307294
Public Version Date
June 30, 2020
Public Version Number
1
DI Record Publish Date
June 22, 2020
Package DI Number
10894046001919
Quantity per Package
20
Contains DI Package
00894046001912
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |