Primary Device ID | 36945630109035 |
NIH Device Record Key | 875c3197-4db1-41a6-bb05-d3114914e8dc |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SteriLance Neoheel Heel Incision Safety Lancet |
Version Model Number | 05-101025 |
Company DUNS | 421141183 |
Company Name | SteriLance Medical (Suzhou) Inc. |
Device Count | 50 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | false |
OTC Over-The-Counter | true |
Device Issuing Agency | Device ID |
---|---|
GS1 | 06945630109034 [Unit of Use] |
GS1 | 16945630109031 [Primary] |
GS1 | 36945630109035 [Package] Contains: 16945630109031 Package: CASE [200 Units] In Commercial Distribution |
FMK | Lancet, Blood |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-12-29 |
Device Publish Date | 2020-12-21 |
36945630109042 | SteriLance Neoheel Heel Incision Safety Lancet,2.0*3.0mm,50Lancets/box |
36945630109035 | SteriLance Neoheel Heel Incision Safety Lancet,1.0*2.5mm,50Lancets/box |
36945630109028 | SteriLance Neoheel Heel Incision Safety Lancet,0.85*1.75mm,50Lancets/box |
36945630108922 | SteriLance Neoheel Heel Incision Safety Lancet,0.65*1.40mm,50Lancets/box |