Primary Device ID | 00812352021295 |
NIH Device Record Key | 2641cd29-4e8a-42b9-9d5f-27ea8dfe0a10 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Royal Oak IBFD Implant System |
Version Model Number | 4502081 |
Company DUNS | 017825896 |
Company Name | Royal Oak Medical Devices LLC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
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 |
Phone | 248-853-1450 |
customerservice@royaloakmed.com | |
Phone | 248-853-1450 |
customerservice@royaloakmed.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00812352021295 [Primary] |
MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00812352021295]
Moist Heat or Steam Sterilization
[00812352021295]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2015-09-22 |
00812352021295 | Royal Oak IBFD Instrument Set Case 2 |
00812352021288 | Royal Oak IBFD Instrument Set Case 1 |
00812352020908 | TLIF Cage 25mm x 16mm |
00812352020892 | TLIF Cage 25mm x 14mm |
00812352020885 | TLIF Cage 25mm x 12mm |
00812352020878 | TLIF Cage 25mm x 10mm |
00812352020861 | TLIF Cage 25mm x 8mm |
00812352020816 | Parallel PLIF Cage 26mm x 16mm |
00812352020809 | Parallel PLIF Cage 26mm x 14mm |
00812352020793 | Parallel PLIF Cage 26mm x 12mm |
00812352020786 | Parallel PLIF Cage 26mm x 10mm |
00812352020779 | Parallel PLIF Cage 26mm x 8mm |
00812352020762 | Parallel PLIF Cage 22mm x 16mm |
00812352020755 | Parallel PLIF Cage 22mm x 14mm |
00812352020748 | Parallel PLIF Cage 22mm x 12mm |
00812352020731 | Parallel PLIF Cage 22mm x 10mm |
00812352020724 | Parallel PLIF Cage 22mm x 8mm |