Primary Device ID | B666MCG80140 |
NIH Device Record Key | a54a4a27-dad2-4f9a-a8cd-b038c3e713ae |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Revolver Universal Drill Bit Guide System |
Version Model Number | 1.0 |
Catalog Number | MCG8014 |
Company DUNS | 078568266 |
Company Name | MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC |
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 |
Phone | 3073156403 |
support@mcginleyinnovations.com | |
Phone | 3073156403 |
support@mcginleyinnovations.com | |
Phone | 3073156403 |
support@mcginleyinnovations.com | |
Phone | 3073156403 |
support@mcginleyinnovations.com | |
Phone | 3073156403 |
support@mcginleyinnovations.com | |
Phone | 3073156403 |
support@mcginleyinnovations.com | |
Phone | 3073156403 |
support@mcginleyinnovations.com | |
Phone | 3073156403 |
support@mcginleyinnovations.com | |
Phone | 3073156403 |
support@mcginleyinnovations.com | |
Phone | 3073156403 |
support@mcginleyinnovations.com | |
Phone | 3073156403 |
support@mcginleyinnovations.com | |
Phone | 3073156403 |
support@mcginleyinnovations.com | |
Phone | 3073156403 |
support@mcginleyinnovations.com | |
Phone | 3073156403 |
support@mcginleyinnovations.com | |
Phone | 3073156403 |
support@mcginleyinnovations.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B666MCG80140 [Primary] |
LXH | Orthopedic Manual Surgical Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[B666MCG80140]
Moist Heat or Steam Sterilization
[B666MCG80140]
Moist Heat or Steam Sterilization
[B666MCG80140]
Moist Heat or Steam Sterilization
[B666MCG80140]
Moist Heat or Steam Sterilization
[B666MCG80140]
Moist Heat or Steam Sterilization
[B666MCG80140]
Moist Heat or Steam Sterilization
[B666MCG80140]
Moist Heat or Steam Sterilization
[B666MCG80140]
Moist Heat or Steam Sterilization
[B666MCG80140]
Moist Heat or Steam Sterilization
[B666MCG80140]
Moist Heat or Steam Sterilization
[B666MCG80140]
Moist Heat or Steam Sterilization
[B666MCG80140]
Moist Heat or Steam Sterilization
[B666MCG80140]
Moist Heat or Steam Sterilization
[B666MCG80140]
Moist Heat or Steam Sterilization
[B666MCG80140]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-12-13 |
Device Publish Date | 2022-12-05 |
B666MCG80150 | Revolver 30mm long x 2.5 attachment for drill bit diameters up to 2.5mm |
B666MCG80140 | Revolver 30mm long x 5.0 attachment for drill bit diameters up to 5.0mm |
B666MCG80130 | Revolver 120mm long x 2.5 attachment for drill bit diameters up to 2.5mm |
B666MCG80120 | Revolver 120mm long x 5.0 attachment for drill bit diameters up to 5.0mm |
B666MCG80110 | Revolver 90mm long x 5.0 attachment for drill bit diameters up to 5.0mm |
B666MCG80100 | Revolver 60mm long x 5.0 attachment for drill bit diameters up to 5.0mm |
B666MCG80090 | Revolver 90mm long x 2.5 attachment for drill bit diameters up to 2.5mm |
B666MCG80080 | Revolver 60mm long x 2.5 attachment for drill bit diameters up to 2.5mm |
B666MCG80000 | Revolver Drill Bit Guide Handle |