Primary Device ID | 00854515008231 |
NIH Device Record Key | c3813a3d-37b8-4bac-b9e5-0da55b79ed4e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Angled Drill Bit |
Version Model Number | 45 Degree Ø3.2 L50 455 SST |
Catalog Number | 1144-32-50-455 |
Company DUNS | 079820535 |
Company Name | Unique Surgical |
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 | 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 | false |
OTC Over-The-Counter | false |
Phone | 818-813-8527 |
info@UniqueSurgical.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00854515008231 [Primary] |
LXH | Orthopedic Manual Surgical Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00854515008231]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-01-13 |
Device Publish Date | 2023-01-05 |
00854515008385 - Tibial Cutting Jig | 2023-06-30 |
00854515008323 - Patella Clamp | 2023-05-03 |
00854515008361 - Alignment Guide | 2023-05-03 |
00854515008101 - Lima Femoral Cutting Block | 2023-01-13 |
00854515008132 - Lima Femoral Cutting Block | 2023-01-13 |
00854515008149 - IM Rod | 2023-01-13 |
00854515008156 - T-Handle | 2023-01-13 |
00854515008231 - Angled Drill Bit | 2023-01-13 |
00854515008231 - Angled Drill Bit | 2023-01-13 |