Primary Device ID | 00850019162387 |
NIH Device Record Key | 3e4190ae-c7ba-4462-90ae-f8539a3d60c4 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Microlyte PainGuard |
Version Model Number | MLPG1010 |
Company DUNS | 962084500 |
Company Name | IMBED BIOSCIENCES, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Unsafe |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | true |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 888-472-9898 |
cs@imbedbio.com | |
Phone | 888-472-9898 |
cs@imbedbio.com | |
Phone | 888-472-9898 |
cs@imbedbio.com | |
Phone | 888-472-9898 |
cs@imbedbio.com | |
Phone | 888-472-9898 |
cs@imbedbio.com | |
Phone | 888-472-9898 |
cs@imbedbio.com | |
Phone | 888-472-9898 |
cs@imbedbio.com | |
Phone | 888-472-9898 |
cs@imbedbio.com | |
Phone | 888-472-9898 |
cs@imbedbio.com | |
Phone | 888-472-9898 |
cs@imbedbio.com | |
Phone | 888-472-9898 |
cs@imbedbio.com | |
Phone | 888-472-9898 |
cs@imbedbio.com |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850019162387 [Primary] |
FRO | Dressing, Wound, Drug |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-08-29 |
Device Publish Date | 2025-08-21 |
00850019162387 | Microlyte PainGuard, 10cm x 10cm |
00850019162370 | Microlyte PainGuard, 5cm x 5cm |
00850019162363 | Microlyte PainGuard, 3cm x 3cm |