Duns Number:007941230
Device Description: Heelstick Lancet Infant Preemie Incision Depth 0.85 Millimeter And Length 1.75 Millimeter Heelstick Lancet Infant Preemie Incision Depth 0.85 Millimeter And Length 1.75 Millimeter Single Use Sterile Not Made With Natural Rubber Latex MediChoice
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
MC5080
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
0a4a9da9-47b4-4918-b80a-60ac57b50ca0
Public Version Date
October 27, 2020
Public Version Number
1
DI Record Publish Date
October 19, 2020
Package DI Number
50885632134492
Quantity per Package
6
Contains DI Package
30885632134498
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |