REFLEX 1805
GUDID 10653405035152
REFLEX 5MM SITE STABILITY DEVICE
Conmed Corporation
Laparoscopic access cannula seal reducer| Primary Device ID | 10653405035152 |
| NIH Device Record Key | 1240b4c3-7f4c-438f-9d36-1a312a02aceb |
| Commercial Distribution Discontinuation | 2022-06-06 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | REFLEX |
| Version Model Number | 1805 |
| Catalog Number | 1805 |
| Company DUNS | 071595540 |
| Company Name | Conmed Corporation |
| 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 | true |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10653405035152 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K924761
FDA Product Code
| GCJ | Laparoscope, general & plastic surgery |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2022-06-07 |
| Device Publish Date | 2016-09-24 |
On-Brand Devices [REFLEX]
| 20653405074813 | REFLEX ELC Endoscopic Clip Applier W/Titanium Clips, 10mm |
| 10653405035206 | REFLEX STR BLADED/SHIELDED SURGICAL TROCAR WITH UNIVERSAL CONVERTER 5/11MM |
| 10653405035176 | REFLEX 5/12MM UNIVERSAL CONVERTER |
| 10653405035008 | REFLEX STR BLADED/SHIELDED SURGICAL TROCAR 10/12MM |
| 10653405034995 | REFLEX STR BLADED/SHIELDED SURGICAL TROCAR WITH UNIVERSAL CONVERTER 5/12MM |
| 10653405034971 | REFLEX STR SURGICAL TROCAR SLEEVE 10/11MM |
| 10653405034957 | REFLEX STR SURGICAL TROCAR SLEEVE 5MM |
| 10653405034940 | REFLEX STR SURGICAL TROCAR SLEEVE 10/12MM |
| 10653405034926 | REFLEXT STR BLUNT TIP SURGICAL TROCAR 10/11MM |
| 10653405034919 | REFLEX STR BLADED/SHIELDED SURGICAL TROCAR 5MM |
| 10653405034896 | REFLEX STR BLADED/SHIELDED SURGICAL TROCAR 10/11MM |
| 10653405034636 | REFLEX STR BLADED/SHIELDED SURGICAL TROCAR 10/12MM LONG |
| 20653405037108 | REFLEX EXTRACTOR WIDE/REGULAR 12/CASE |
| 10653405050896 | Reflex TL, Skin Stapler with tissue lift, 35 regular |
| 10653405050605 | Reflex TL, Skin Stapler with tissue lift, 35 wide |
| 10653405050599 | Reflex One, Skin Stapler, 35 regular |
| 10653405048381 | Reflex One, Skin Stapler, 35 wide |
| 10653405037019 | Reflex TL, Skin Stapler with tissue lift, 35 wide |
| 10653405036982 | Reflex TL, Skin Stapler with tissue lift, 35 regular |
| 10653405036951 | Reflex One, Skin Stapler, 35 wide |
| 10653405036920 | Reflex One, Skin Stapler, 35 regular |
| 00653405037258 | REFLEX TL SKIN STAPLER WITH TISSUE LIFT, 35 WIDE: FURTHER PROCESSING REQUIRED |
| 00653405037234 | REFLEX ONE SKIN STAPLER, 35 WIDE: FURTHER PROCESSING REQUIRED |
| 10653405035152 | REFLEX 5MM SITE STABILITY DEVICE |
| 10653405035138 | REFLEX 10/12MM SITE STABILITY DEVICE |
| 10653405035114 | REFLEX 10/11MM SITE STABILITY DEVICE |
| 10653405035190 | CONVERTER 5MM SINGLE-USE |
Trademark Results [REFLEX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 REFLEX 98641749 not registered Live/Pending |
CONTINENTAL FINANCE COMPANY, LLC 2024-07-10 |
 REFLEX 98500638 not registered Live/Pending |
Timeback Incorporated 2024-04-15 |
 REFLEX 98461627 not registered Live/Pending |
iFIT INC. 2024-03-21 |
 REFLEX 98256348 not registered Live/Pending |
Mister Addons LLC 2023-11-06 |
 REFLEX 98236511 not registered Live/Pending |
Selkirk Sport, LLC 2023-10-23 |
 REFLEX 98212548 not registered Live/Pending |
OnLogic, Inc. 2023-10-06 |
 REFLEX 98088696 not registered Live/Pending |
REFLEX WIRELESS INC. 2023-07-17 |
 REFLEX 98042886 not registered Live/Pending |
Pynecone, Inc. 2023-06-14 |
 REFLEX 97831153 not registered Live/Pending |
REFLEX LLC 2023-03-09 |
 REFLEX 97566950 not registered Live/Pending |
Munich Re Specialty Group Insurance Services, Inc. 2022-08-26 |
 REFLEX 97436350 not registered Live/Pending |
Ariens Company 2022-05-31 |
 REFLEX 97083772 not registered Live/Pending |
FXI, Inc. 2021-10-20 |
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