Primary Device ID | 00718175003657 |
NIH Device Record Key | c906086e-96a1-48b7-90e5-713cca3a691a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Neck Phantom |
Version Model Number | 043-365 |
Catalog Number | 043-365 |
Company DUNS | 043833813 |
Company Name | BIODEX MEDICAL 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 | false |
Serial Number | false |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00718175003657 [Primary] |
IYP | Phantom, Anthropomorphic, Nuclear |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2018-02-15 |
00718175002407 - Biostep 2, 100-240 VAC | 2024-05-14 950-240 Biostep 2, 100-240 VAC |
00718175006009 - Reactive Step Trainer 115V | 2024-05-14 950-600 Reactive Step Trainer 115V |
00718175001462 - Biodex | 2023-08-10 CYCLE, UPPER BODY |
00718175001486 - Biodex | 2023-08-10 CYCLE, UPPER BODY - CLINICAL PRO |
00718175005606 - Sit2Stand | 2023-08-08 SIT2STAND SQUAT-ASSIST TRAINER |
00718175004302 - VibroTactile | 2023-07-27 VIBROTACTILE BELT KIT |
00718175087640 - BETA, Syringe Shield | 2021-01-15 BETA, Lead Encapsulated Syringe Shield, 20cc |
00718175087626 - VENTI-SCAN IV | 2020-10-23 Venti-Scan IV, Includes shielded canister with IV pole mount |