Primary Device ID | 00850018135399 |
NIH Device Record Key | 2d62858b-0381-45f2-8397-ba49505e1aeb |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Smartwire InGager |
Version Model Number | 85001 |
Catalog Number | 85001 |
Company DUNS | 884398210 |
Company Name | SWIFT HEALTH SYSTEMS INC. |
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 | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850018135399 [Primary] |
DZN | Instruments, Dental Hand |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00850018135399]
Moist Heat or Steam Sterilization
[00850018135399]
Moist Heat or Steam Sterilization
[00850018135399]
Moist Heat or Steam Sterilization
[00850018135399]
Moist Heat or Steam Sterilization
[00850018135399]
Moist Heat or Steam Sterilization
[00850018135399]
Moist Heat or Steam Sterilization
[00850018135399]
Moist Heat or Steam Sterilization
[00850018135399]
Moist Heat or Steam Sterilization
[00850018135399]
Moist Heat or Steam Sterilization
[00850018135399]
Moist Heat or Steam Sterilization
[00850018135399]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-11-15 |
Device Publish Date | 2021-11-07 |
00850018135122 - Inbrace Teeth Straightening System | 2022-10-11 |
10850018135396 - InBrace Starter Kit | 2021-12-02 This device is a kit containing 3 Smartwire InGager instruments and spare brackets for use with InBrace Teeth Straightening Syst |
00850018135009 - Inbrace Teeth Straightening System | 2021-11-15 |
00850018135016 - Inbrace Teeth Straightening System | 2021-11-15 |
00850018135030 - InBrace Teeth Straightening System (Gen 2.0) | 2021-11-15 |
00850018135047 - InBrace Teeth Straightening System (Gen 2.0) | 2021-11-15 |
00850018135054 - InBrace Teeth Straightening System (Gen 2.0) | 2021-11-15 |
00850018135139 - Inbrace Teeth Straightening System | 2021-11-15 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() SMARTWIRE INGAGER 97035867 not registered Live/Pending |
Swift Health Systems Inc. 2021-09-20 |