Angioscope A5401
GUDID 00840663106882
Angioscope light post adaptor
LEMAITRE VASCULAR, INC.
Flexible fibreoptic angioscope, single-use| Primary Device ID | 00840663106882 |
| NIH Device Record Key | 48b0c71c-ffc8-4720-a2ef-f77c52aefd4d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Angioscope |
| Version Model Number | A5401 |
| Catalog Number | A5401 |
| Company DUNS | 184805166 |
| Company Name | LEMAITRE VASCULAR, 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 | false |
| Lot Batch | true |
| 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 | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 781-221-2266 |
| csus@lemaitre.com | |
| Phone | 781-221-2266 |
| csus@lemaitre.com | |
| Phone | 781-221-2266 |
| csus@lemaitre.com | |
| Phone | 781-221-2266 |
| csus@lemaitre.com | |
| Phone | 781-221-2266 |
| csus@lemaitre.com | |
| Phone | 781-221-2266 |
| csus@lemaitre.com | |
| Phone | 781-221-2266 |
| csus@lemaitre.com | |
| Phone | 781-221-2266 |
| csus@lemaitre.com | |
| Phone | 781-221-2266 |
| csus@lemaitre.com | |
| Phone | 781-221-2266 |
| csus@lemaitre.com | |
| Phone | 781-221-2266 |
| csus@lemaitre.com | |
| Phone | 781-221-2266 |
| csus@lemaitre.com | |
| Phone | 781-221-2266 |
| csus@lemaitre.com | |
| Phone | 781-221-2266 |
| csus@lemaitre.com | |
| Phone | 781-221-2266 |
| csus@lemaitre.com | |
| Phone | 781-221-2266 |
| csus@lemaitre.com | |
| Phone | 781-221-2266 |
| csus@lemaitre.com | |
| Phone | 781-221-2266 |
| csus@lemaitre.com | |
| Phone | 781-221-2266 |
| csus@lemaitre.com | |
| Phone | 781-221-2266 |
| csus@lemaitre.com | |
| Phone | 781-221-2266 |
| csus@lemaitre.com | |
| Phone | 781-221-2266 |
| csus@lemaitre.com | |
| Phone | 781-221-2266 |
| csus@lemaitre.com | |
| Phone | 781-221-2266 |
| csus@lemaitre.com | |
| Phone | 781-221-2266 |
| csus@lemaitre.com | |
| Phone | 781-221-2266 |
| csus@lemaitre.com | |
| Phone | 781-221-2266 |
| csus@lemaitre.com | |
| Phone | 781-221-2266 |
| csus@lemaitre.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840663106882 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K903848
FDA Product Code
| DQO | Catheter, Intravascular, Diagnostic |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840663106882]
Moist Heat or Steam Sterilization
[00840663106882]
Moist Heat or Steam Sterilization
[00840663106882]
Moist Heat or Steam Sterilization
[00840663106882]
Moist Heat or Steam Sterilization
[00840663106882]
Moist Heat or Steam Sterilization
[00840663106882]
Moist Heat or Steam Sterilization
[00840663106882]
Moist Heat or Steam Sterilization
[00840663106882]
Moist Heat or Steam Sterilization
[00840663106882]
Moist Heat or Steam Sterilization
[00840663106882]
Moist Heat or Steam Sterilization
[00840663106882]
Moist Heat or Steam Sterilization
[00840663106882]
Moist Heat or Steam Sterilization
[00840663106882]
Moist Heat or Steam Sterilization
[00840663106882]
Moist Heat or Steam Sterilization
[00840663106882]
Moist Heat or Steam Sterilization
[00840663106882]
Moist Heat or Steam Sterilization
[00840663106882]
Moist Heat or Steam Sterilization
[00840663106882]
Moist Heat or Steam Sterilization
[00840663106882]
Moist Heat or Steam Sterilization
[00840663106882]
Moist Heat or Steam Sterilization
[00840663106882]
Moist Heat or Steam Sterilization
[00840663106882]
Moist Heat or Steam Sterilization
[00840663106882]
Moist Heat or Steam Sterilization
[00840663106882]
Moist Heat or Steam Sterilization
[00840663106882]
Moist Heat or Steam Sterilization
[00840663106882]
Moist Heat or Steam Sterilization
[00840663106882]
Moist Heat or Steam Sterilization
[00840663106882]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2015-07-15 |
On-Brand Devices [Angioscope]
| 00840663106882 | Angioscope light post adaptor |
| 00840663106875 | Angioscope 1.7mm 100cm |
| 00840663106868 | Angioscope 2.3mm 80cm |
Trademark Results [Angioscope]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ANGIOSCOPE 73424457 not registered Dead/Abandoned |
TRIMEDYNE, INC. 1983-05-04 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.