SHARPSITE®
GUDID 00681490046985
ENDOSCOPE 1880155 SHARPSITE 4MM/45DEG
MEDTRONIC XOMED, INC.
Rigid nasopharyngoscope Rigid nasopharyngoscope Rigid optical nasopharyngoscope Rigid optical nasopharyngoscope Rigid optical nasopharyngoscope Rigid optical nasopharyngoscope Rigid optical nasopharyngoscope Rigid optical nasopharyngoscope Rigid optical nasopharyngoscope Rigid optical nasopharyngoscope Rigid optical nasopharyngoscope Rigid optical nasopharyngoscope Rigid optical nasopharyngoscope Rigid optical nasopharyngoscope Rigid optical nasopharyngoscope Rigid optical nasopharyngoscope Rigid optical nasopharyngoscope Rigid optical nasopharyngoscope Rigid optical nasopharyngoscope| Primary Device ID | 00681490046985 |
| NIH Device Record Key | 325a256b-1d86-4420-a200-535c152b4305 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SHARPSITE® |
| Version Model Number | 1880155 |
| Company DUNS | 835465063 |
| Company Name | MEDTRONIC XOMED, 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 | false |
| 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)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Device Dimensions
| Outer Diameter | 4 Millimeter |
| Outer Diameter | 4 Millimeter |
| Outer Diameter | 4 Millimeter |
| Outer Diameter | 4 Millimeter |
| Angle | 45 degree |
| Outer Diameter | 4 Millimeter |
| Angle | 45 degree |
| Outer Diameter | 4 Millimeter |
| Angle | 45 degree |
| Outer Diameter | 4 Millimeter |
| Angle | 45 degree |
| Outer Diameter | 4 Millimeter |
| Angle | 45 degree |
| Outer Diameter | 4 Millimeter |
| Angle | 45 degree |
| Outer Diameter | 4 Millimeter |
| Angle | 45 degree |
| Outer Diameter | 4 Millimeter |
| Angle | 45 degree |
| Outer Diameter | 4 Millimeter |
| Angle | 45 degree |
| Outer Diameter | 4 Millimeter |
| Angle | 45 degree |
| Outer Diameter | 4 Millimeter |
| Angle | 45 degree |
| Outer Diameter | 4 Millimeter |
| Angle | 45 degree |
| Outer Diameter | 4 Millimeter |
| Angle | 45 degree |
| Outer Diameter | 4 Millimeter |
| Angle | 45 degree |
| Outer Diameter | 4 Millimeter |
| Angle | 45 degree |
| Outer Diameter | 4 Millimeter |
| Angle | 45 degree |
| Outer Diameter | 4 Millimeter |
| Angle | 45 degree |
| Outer Diameter | 4 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00681490046985 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K965233
FDA Product Code
| EOB | NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID) |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00681490046985]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00681490046985]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00681490046985]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00681490046985]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00681490046985]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00681490046985]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00681490046985]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00681490046985]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00681490046985]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00681490046985]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00681490046985]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00681490046985]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00681490046985]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00681490046985]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00681490046985]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00681490046985]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00681490046985]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00681490046985]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00681490046985]
Ethylene Oxide;Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-05-05 |
On-Brand Devices [SHARPSITE®]
| 00613994672285 | ENDOSCOPE 1880153DL 4MM/30 DEG DONATE |
| 00613994672278 | ENDOSCOPE 1880152DL 4MM/0 DEG DONATE |
| 00613994455383 | ENDOSCOPE 1880525 SHARPSITE FLEX 3.2MM |
| 00613994128270 | ENDOSCOPE 1880161X SHARPSITE X 2.7MM/30D |
| 00613994128263 | ENDOSCOPE 1880160X SHARPSITE X 2.7MM/0DG |
| 00613994128256 | ENDOSCOPE 1880155X SHARPSITE X 4MM/45DG |
| 00613994128249 | ENDOSCOPE 1880154X SHARPSITE X 4MM/70DG |
| 00613994128232 | ENDOSCOPE 1880153X SHARPSITE X 4MM/30DG |
| 00613994128225 | ENDOSCOPE 1880152X SHARPSITE X 4MM/0DG |
| 00643169937475 | ENDOSCOPE 1880161X SHARPSITE X 2.7MM/30D |
| 00643169937468 | ENDOSCOPE 1880160X SHARPSITE X 2.7MM/0DG |
| 00643169937451 | ENDOSCOPE 1880155X SHARPSITE X 4MM/45DG |
| 00643169937444 | ENDOSCOPE 1880154X SHARPSITE X 4MM/70DG |
| 00643169937437 | ENDOSCOPE 1880153X SHARPSITE X 4MM/30DG |
| 00643169937420 | ENDOSCOPE 1880152X SHARPSITE X 4MM/0DG |
| 00643169937413 | ENDOSCOPE 1880161 SHARPSITE 2.7MM/30DEG |
| 00643169937406 | ENDOSCOPE 1880160 SHARPSITE 2.7MM/0DEG |
| 00643169937390 | ENDOSCOPE 1880155 SHARPSITE 4MM/45DEG |
| 00643169937383 | ENDOSCOPE 1880154 SHARPSITE 4MM/70DEG |
| 00643169937376 | ENDOSCOPE 1880153 SHARPSITE 4MM/30DEG |
| 00643169937369 | ENDOSCOPE 1880152 SHARPSITE 4MM/0DEG |
| 00681490047036 | ENDOSCOPE 1880161 SHARPSITE 2.7MM/30DEG |
| 00681490046992 | ENDOSCOPE 1880160 SHARPSITE 2.7MM/0DEG |
| 00681490046985 | ENDOSCOPE 1880155 SHARPSITE 4MM/45DEG |
| 00681490046947 | ENDOSCOPE 1880154 SHARPSITE 4MM/70DEG |
| 00681490046893 | ENDOSCOPE 1880153 SHARPSITE 4MM/30DEG |
| 00681490046855 | ENDOSCOPE 1880152 SHARPSITE 4MM/0DEG |
| 00885074017747 | ENDOSCOPE 1880500 SHARPSITE FLEX 3.8MM |
| 00763000172107 | INSTR TRAY 1881000 SHARPSITE AC ENDOSCPE |
Trademark Results [SHARPSITE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SHARPSITE 78685788 not registered Dead/Abandoned |
Medtronic Xomed, Inc. 2005-08-04 |
 SHARPSITE 77725396 not registered Dead/Abandoned |
Jolley Chris 2009-04-29 |
 SHARPSITE 77238945 not registered Dead/Abandoned |
AEPCO, Inc. 2007-07-25 |
 SHARPSITE 75385488 2208958 Live/Registered |
Medtronic Xomed, Inc. 1997-11-05 |
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