Mixter OS-5-265
GUDID B354OS52650
Mixter
ORANGE SURGICAL INSTRUMENTS, LLC
Endoscopic electrosurgical handpiece/electrode, monopolar, reusable| Primary Device ID | B354OS52650 |
| NIH Device Record Key | 8b2ed487-19e0-4ccd-9745-b9dfe222ecc3 |
| Commercial Distribution Discontinuation | 2019-11-15 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Mixter |
| Version Model Number | OS-5-265 |
| Catalog Number | OS-5-265 |
| Company DUNS | 047063695 |
| Company Name | ORANGE SURGICAL INSTRUMENTS, LLC |
| 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 | 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B354OS52650 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K101733
FDA Product Code
| GEI | Electrosurgical, Cutting & Coagulation & Accessories |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
[B354OS52650]
Peracetic Acid
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-11-15 |
| Device Publish Date | 2016-11-15 |
Devices Manufactured by ORANGE SURGICAL INSTRUMENTS, LLC
| B354OS335MGTI0 - Grasper Traumatic Shaft insert 33 cm Disposable | 2025-02-18 |
| B354OS335MGTR0 - Grasper Traumatic with ratchet 33cm Disposable | 2025-02-18 |
| B354OS445RTG0 - Rat Tooth Grasper, 44cm, Disposable | 2025-02-18 |
| B354OS445RTGR0 - Rat Tooth Grasper w/Ratchet, 44cm, Disposable | 2025-02-18 |
| B354OSMCR4MMX5MR0 - 4mm Plug x 5M Monopolar Cable Reusable | 2025-02-18 |
| B354HAF2LGS0 - Stainless Steel Cardiac 2 Finger Heart Retractor - Small | 2025-01-17 Stainless Steel Cardiac 2 Finger Heart Retractor - Small Heart Assist, Single Use, 2 Finger Long, Malleable, 63mm W x 90mm L |
| B354HAF2SHS0 - Stainless Steel Cardiac 2 Finger Heart Retractor - Large | 2025-01-17 Stainless Steel Cardiac 2 Finger Heart Retractor - Large Heart Assist, Sing Use, 2 Finger Short, Malleable 36mm x 54mm |
| B354HAF3LGS0 - Stainless Steel Cardiac 3 Finger Heart Retractor - Small | 2025-01-17 Stainless Steel Cardiac 3 Finger Heart Retractor - Small Heart Assist, Single Use, 3 Finger Long, Malleable, 60mm W x 90mm |
Trademark Results [Mixter]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MIXTER 78617399 not registered Dead/Abandoned |
MISS MATCHED, INC. 2005-04-26 |
 MIXTER 78612346 not registered Dead/Abandoned |
MATTEL, INC. 2005-04-19 |
 MIXTER 76072746 not registered Dead/Abandoned |
New Technology Holdings, Inc. 2000-06-19 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.