Primary Device ID | 00810071230592 |
NIH Device Record Key | a8b1ae47-45da-4a1d-bd13-91aa5d3fb3df |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Regenalase |
Version Model Number | MD2300F-002245 |
Company DUNS | 081504133 |
Company Name | IPG Medical Corporation |
Device Count | 1 |
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 | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00810071230592 [Primary] |
ILY | Lamp, Infrared, Therapeutic Heating |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-06-16 |
Device Publish Date | 2025-06-08 |
00810071230592 | Attachment Head D |
00810071230585 | Attachment Head B2 |
00810071230578 | Attachment Head C |
00810071230554 | Attachment Head B1 |
00810071230547 | Universal Stage One Handpiece |
00810071230530 | Laser System |
00810071230523 | Wired Footswitch |
00810071230516 | Regenalase Therapy Kit, Regenalase Photobiomodulation (PBM) Kit |
00810071230509 | Laser System |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() REGENALASE 98639251 not registered Live/Pending |
IPG Photonics Corporation 2024-07-09 |
![]() REGENALASE 98595766 not registered Live/Pending |
IPG Photonics Corporation 2024-06-11 |
![]() REGENALASE 88858490 not registered Live/Pending |
Endocellutions, Inc. 2020-04-03 |
![]() REGENALASE 88858489 not registered Live/Pending |
Endocellutions, Inc. 2020-04-03 |