Primary Device ID | 10841470103825 |
NIH Device Record Key | 902b6352-0d27-4aec-99ad-96d7a21605f2 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | DART-Reach |
Version Model Number | 301-REACH700 |
Company DUNS | 154502934 |
Company Name | ENGINEERED MEDICAL SYSTEMS INC |
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 | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Length | 218 Millimeter |
Length | 218 Millimeter |
Length | 218 Millimeter |
Length | 218 Millimeter |
Length | 218 Millimeter |
Length | 218 Millimeter |
Length | 218 Millimeter |
Length | 218 Millimeter |
Length | 218 Millimeter |
Length | 218 Millimeter |
Length | 218 Millimeter |
Length | 218 Millimeter |
Length | 218 Millimeter |
Length | 218 Millimeter |
Length | 218 Millimeter |
Length | 218 Millimeter |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00841470103828 [Primary] |
GS1 | 10841470103825 [Package] Contains: 00841470103828 Package: [25 Units] In Commercial Distribution |
CCT | Applicator (Laryngo-Tracheal), Topical Anesthesia |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-04-04 |
Device Publish Date | 2022-03-25 |
10841470103825 | 301-REACH700 |
10841470103818 | 301-REACH720 |
10841470103801 | 301-REACH600 |