SurgiLux™ SL-12
GUDID M710SL122
BIOTEX, INC.
Operating light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light| Primary Device ID | M710SL122 |
| NIH Device Record Key | c1ec1083-5af4-4543-8987-535d8dac1283 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SurgiLux™ |
| Version Model Number | SL-12 |
| Catalog Number | SL-12 |
| Company DUNS | 969792050 |
| Company Name | BIOTEX, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
Customer Support Contacts
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx |
Operating and Storage Conditions
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M710SL120 [Primary] |
| HIBCC | M710SL122 [Package] Contains: M710SL120 Package: Dispenser & 1-pack [12 Units] In Commercial Distribution |
| HIBCC | M710SL124 [Package] Contains: M710SL120 Package: 4-pack [48 Units] In Commercial Distribution |
FDA Product Code
| FTD | Lamp, Surgical |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-07-09 |
| Device Publish Date | 2019-07-01 |
Devices Manufactured by BIOTEX, INC.
| M710TCW101200 - Bayou™ troCarWash System Disposable Kit | 2024-02-08 |
| M71003810000 - Bayou™ troCarWash System Disposable Kit | 2023-08-14 |
| M71003850000 - Bayou™ troCarWash System Controller | 2023-08-14 |
| M71004615000 - The Slide® | 2023-05-29 Slide Nylon. |
| M71002110010 - Wire Watch™ | 2023-02-17 |
| M710ERGUIDE10102 - OcciGuide | 2022-06-17 |
| M71004610000 - The Slide™ | 2021-09-09 |
| M710ERGUIDE10052 - OcciGuide | 2021-03-05 |
Trademark Results [SurgiLux]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SURGILUX 88599276 not registered Live/Pending |
Surgilux Medical LLC 2019-08-30 |
 SURGILUX 87569444 not registered Dead/Abandoned |
Surgilux Medical LLC 2017-08-15 |
 SURGILUX 85692013 not registered Dead/Abandoned |
SFB LLC 2012-08-01 |
 SURGILUX 76539747 2853326 Dead/Cancelled |
Aculux, Inc. 2003-08-05 |
 SURGILUX 74335379 not registered Dead/Abandoned |
MIDMARK CORPORATION 1992-11-30 |
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