Arthrex® RAR-3351-5545
GUDID 00888867188990
5MM, 45DEG. LAPAROSCOPE, STANDARD
ARTHREX, INC.
Rigid optical laparoscope| Primary Device ID | 00888867188990 |
| NIH Device Record Key | c402b180-588c-4bef-868d-9e76938b29b1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Arthrex® |
| Version Model Number | RAR-3351-5545 |
| Catalog Number | RAR-3351-5545 |
| Company DUNS | 131747628 |
| Company Name | ARTHREX, 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 | true |
| Manufacturing Date | false |
| 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 | +1(800)934-4404 |
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 |
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 |
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 |
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 |
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 |
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 |
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 |
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 |
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 |
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 |
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 |
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 |
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 |
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 |
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 |
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 |
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 |
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 |
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 |
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 |
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 |
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 |
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 |
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 |
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 |
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 |
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 |
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 |
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 |
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 |
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 |
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 |
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 |
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 |
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 |
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 |
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 |
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 |
| complaints@arthrex.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00888867188990 [Primary] |
| HIBCC | M150RAR335155450 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K941541
FDA Product Code
| GCJ | Laparoscope, general & plastic surgery |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00888867188990]
Moist Heat or Steam Sterilization
[00888867188990]
Moist Heat or Steam Sterilization
[00888867188990]
Moist Heat or Steam Sterilization
[00888867188990]
Moist Heat or Steam Sterilization
[00888867188990]
Moist Heat or Steam Sterilization
[00888867188990]
Moist Heat or Steam Sterilization
[00888867188990]
Moist Heat or Steam Sterilization
[00888867188990]
Moist Heat or Steam Sterilization
[00888867188990]
Moist Heat or Steam Sterilization
[00888867188990]
Moist Heat or Steam Sterilization
[00888867188990]
Moist Heat or Steam Sterilization
[00888867188990]
Moist Heat or Steam Sterilization
[00888867188990]
Moist Heat or Steam Sterilization
[00888867188990]
Moist Heat or Steam Sterilization
[00888867188990]
Moist Heat or Steam Sterilization
[00888867188990]
Moist Heat or Steam Sterilization
[00888867188990]
Moist Heat or Steam Sterilization
[00888867188990]
Moist Heat or Steam Sterilization
[00888867188990]
Moist Heat or Steam Sterilization
[00888867188990]
Moist Heat or Steam Sterilization
[00888867188990]
Moist Heat or Steam Sterilization
[00888867188990]
Moist Heat or Steam Sterilization
[00888867188990]
Moist Heat or Steam Sterilization
[00888867188990]
Moist Heat or Steam Sterilization
[00888867188990]
Moist Heat or Steam Sterilization
[00888867188990]
Moist Heat or Steam Sterilization
[00888867188990]
Moist Heat or Steam Sterilization
[00888867188990]
Moist Heat or Steam Sterilization
[00888867188990]
Moist Heat or Steam Sterilization
[00888867188990]
Moist Heat or Steam Sterilization
[00888867188990]
Moist Heat or Steam Sterilization
[00888867188990]
Moist Heat or Steam Sterilization
[00888867188990]
Moist Heat or Steam Sterilization
[00888867188990]
Moist Heat or Steam Sterilization
[00888867188990]
Moist Heat or Steam Sterilization
[00888867188990]
Moist Heat or Steam Sterilization
[00888867188990]
Moist Heat or Steam Sterilization
[00888867188990]
Moist Heat or Steam Sterilization
[00888867188990]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-03-13 |
| Device Publish Date | 2017-02-15 |
On-Brand Devices [Arthrex®]
| 10888867084008 | ANGEL cPRP PROCESSING SET US |
| 10888867020808 | DISP INSTR. KIT FOR TENO SCRW |
| 10888867018645 | DISPS KIT FOR 3X 8MM TENO |
| M150AR8942RLS1 | H-PLATE, 36 X 16MM RIGHT, LARGE, STRL |
| M150AR8942LMS1 | H-PLATE, 32 X 16MM, LEFT, MED, STRL |
| 00888867020771 | IMPL SYS,LAT ANKLE RECON |
| 00888867008786 | TIB OPEN WEDGE OSTEO PLATE, 17.5 MM |
| 00888867008762 | TIB OPEN WEDGE OSTEO PLATE, 16 MM |
| 00888867008724 | TIB OPEN WEDGE OSTEO PLATE, 13.5 MM |
| 00888867008700 | TIB OPEN WEDGE OSTEO PLATE, 12.5 MM |
| 00888867008663 | TIB OPEN WEDGE OSTEO PLATE, 10 MM |
| 00888867008649 | TIB OPEN WEDGE OSTEO PLATE, 9 MM |
| 00888867008625 | TIB OPEN WEDGE OSTEO PLATE, 7.5 MM |
| 00888867008601 | TIB OPEN WEDGE OSTEO PLATE, 6 MM |
| 00888867008588 | TIB OPEN WEDGE OSTEO PLATE, 5 MM |
| 00888867007581 | FEM OPENG WEDG OSTEO PLT,12.5MM |
| 00888867007543 | FEM OPENG WEDG OSTEO PLT,10MM |
| 00888867007505 | FEM OPENG WEDG OSTEO PLT,7.5MM |
| M150AR8951LRS1 | LISFRANC PLATE, LARGE, RIGHT,TI, STRL |
| M150AR8951MRS1 | LISFRANC PLATE, MEDIUM,RIGHT,TI, STRL |
| M150AR8951SRS1 | LISFRANC PLATE, SMALL, RIGHT TI, STRL |
| M150AR8951LLS1 | LISFRANC PLATE, LARGE, LEFT, TI, STRL |
| M150AR8951MLS1 | LISFRANC PLATE, MEDIUM, LEFT,TI, STRL |
| M150AR8951SLS1 | LISFRANC PLATE, SMALL, LEFT, TI, STRL |
| 00888867009608 | 17.5 MM TIBIAL A/P SLOPED OSTEO PLATE |
| 00888867009585 | 16MM, TIBIAL A/P SLOPED OSTEOTOMY PLATE |
| 00888867009561 | 15 MM TIBIAL A/P SLOPED OSTEO PLATE |
| 00888867009547 | 13.5MMTIB A/P SLPD OSTEO PLT |
| 00888867009523 | 12.5 MM TIBIAL A/P SLOPED OSTEO PLATE |
| 00888867009509 | 11.0 MM TIBIAL A/P SLOPED OSTEO PLATE |
| 00888867009462 | 9 MM TIBIAL A/P SLOPED OSTEO PLATE |
| 00888867009448 | 7.5 MM TIBIAL A/P SLOPED OSTEO PLATE |
| 00888867009424 | 6MM, TIBIAL A/P SLOPED OSTEOTOMY PLATE |
| 00888867009400 | 5 MM TIBIAL A/P SLOPED OSTEO PLATE |
| M150AR700040FTS1 | CANN SCRW 3.75X 40MMFULLY THRDED, STRL |
| M150AR700028FTS1 | CANN SCRW,3.75X 28MMFULLY THRDED, STRL |
| M150AR700026FTS1 | CANN SCRW,3.75X 26MMFULLY THRDED, STRL |
| M150AR8916VNC34S1 | 2.4X34MM VAL NEAR CORTEX SCREW, Ti, STRL |
| M150AR8916VNC32S1 | 2.4X32MM VAL NEAR CORTEX SCREW, Ti, STRL |
| M150AR8916VNC30S1 | 2.4X30MM VAL NEAR CORTEX SCREW, Ti, STRL |
| M150AR8916VNC28S1 | 2.4X28MM VAL NEAR CORTEX SCREW, Ti, STRL |
| M150AR8916VNC26S1 | 2.4X26MM VAL NEAR CORTEX SCREW, Ti, STRL |
| M150AR8916VNC24S1 | 2.4X24MM VAL NEAR CORTEX SCREW, Ti, STRL |
| M150AR8916VNC22S1 | 2.4X22MM VAL NEAR CORTEX SCREW, Ti, STRL |
| M150AR8916VNC20S1 | 2.4X20MM VAL NEAR CORTEX SCREW, Ti, STRL |
| M150AR8916VNC18S1 | 2.4X18MM VAL NEAR CORTEX SCREW, Ti, STRL |
| M150AR8916VNC16S1 | 2.4X16MM VAL NEAR CORTEX SCREW, Ti, STRL |
| M150AR8916VNC14S1 | 2.4X14MM VAL NEAR CORTEX SCREW, Ti, STRL |
| M150AR8916VNC12S1 | 2.4X12MM VAL NEAR CORTEX SCREW, Ti, STRL |
| M150AR8916VNC10S1 | 2.4X10MM VAL NEAR CORTEX SCREW,Ti, STRL |
Trademark Results [Arthrex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ARTHREX 87595305 5598566 Live/Registered |
Arthrex, Inc. 2017-09-04 |
 ARTHREX 87595302 5598565 Live/Registered |
Arthrex, Inc. 2017-09-04 |
 ARTHREX 85078407 3911238 Live/Registered |
Arthrex, Inc. 2010-07-06 |
 ARTHREX 74317485 1788030 Live/Registered |
ARTHREX INC. 1992-09-24 |
 ARTHREX 74128118 not registered Dead/Abandoned |
Arthrex Arthroscopy Instruments, Inc. 1991-01-04 |
 ARTHREX 73436631 1328327 Dead/Cancelled |
Surgical Equipment Associates, Ltd. 1983-07-28 |
 ARTHREX 73281788 1191044 Dead/Cancelled |
Gerchenson; Emile H. 1980-10-14 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.