Primary Device ID | 00850010651088 |
NIH Device Record Key | f61a0e85-a5b9-4ec3-a162-489b7f5d8ff7 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Silent Scan |
Version Model Number | 3200 |
Company DUNS | 802279984 |
Company Name | AVOTEC, INC. |
Device Count | 1 |
DM Exempt | true |
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 | true |
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 | 7726920750 |
sales@avotecinc.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850010651088 [Primary] |
LNH | System, Nuclear Magnetic Resonance Imaging |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-05-14 |
Device Publish Date | 2020-05-06 |
00850010651101 | Complete Silent Scan 3200 system |
00850010651095 | Complete Silent Scan 3300 system. |
00850010651088 | Silent Scan 3200 console |
00850010651071 | Silent Scan 3300 console |
00850010651040 | Silent Scan Audio Transducer |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() SILENT SCAN 85789426 4578332 Live/Registered |
Avotec, Inc. 2012-11-28 |