Opti-Tatt™ Crosshairs UTRT-4200
GUDID 00714646001108
Opti-Tatt, Crosshair, Sheet of 24
Bionix, LLC
Skin marking sticker| Primary Device ID | 00714646001108 |
| NIH Device Record Key | 55e44289-a9a5-41f8-a286-57701b2331a3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Opti-Tatt™ Crosshairs |
| Version Model Number | UTRT-4200 |
| Catalog Number | UTRT-4200 |
| Company DUNS | 117844489 |
| Company Name | Bionix, LLC |
| Device Count | 24 |
| DM Exempt | true |
| Pre-market Exempt | true |
| 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 | 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 | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *To maximize shelf-life, keep Opti-Tatt in the freezer between use |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *To maximize shelf-life, keep Opti-Tatt in the freezer between use |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *To maximize shelf-life, keep Opti-Tatt in the freezer between use |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *To maximize shelf-life, keep Opti-Tatt in the freezer between use |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *To maximize shelf-life, keep Opti-Tatt in the freezer between use |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *To maximize shelf-life, keep Opti-Tatt in the freezer between use |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *To maximize shelf-life, keep Opti-Tatt in the freezer between use |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *To maximize shelf-life, keep Opti-Tatt in the freezer between use |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *To maximize shelf-life, keep Opti-Tatt in the freezer between use |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *To maximize shelf-life, keep Opti-Tatt in the freezer between use |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *To maximize shelf-life, keep Opti-Tatt in the freezer between use |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *To maximize shelf-life, keep Opti-Tatt in the freezer between use |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *To maximize shelf-life, keep Opti-Tatt in the freezer between use |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *To maximize shelf-life, keep Opti-Tatt in the freezer between use |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *To maximize shelf-life, keep Opti-Tatt in the freezer between use |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *To maximize shelf-life, keep Opti-Tatt in the freezer between use |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *To maximize shelf-life, keep Opti-Tatt in the freezer between use |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *To maximize shelf-life, keep Opti-Tatt in the freezer between use |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *To maximize shelf-life, keep Opti-Tatt in the freezer between use |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *To maximize shelf-life, keep Opti-Tatt in the freezer between use |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *To maximize shelf-life, keep Opti-Tatt in the freezer between use |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *To maximize shelf-life, keep Opti-Tatt in the freezer between use |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *To maximize shelf-life, keep Opti-Tatt in the freezer between use |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *To maximize shelf-life, keep Opti-Tatt in the freezer between use |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *To maximize shelf-life, keep Opti-Tatt in the freezer between use |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *To maximize shelf-life, keep Opti-Tatt in the freezer between use |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *To maximize shelf-life, keep Opti-Tatt in the freezer between use |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *To maximize shelf-life, keep Opti-Tatt in the freezer between use |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *To maximize shelf-life, keep Opti-Tatt in the freezer between use |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *To maximize shelf-life, keep Opti-Tatt in the freezer between use |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *To maximize shelf-life, keep Opti-Tatt in the freezer between use |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *To maximize shelf-life, keep Opti-Tatt in the freezer between use |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *To maximize shelf-life, keep Opti-Tatt in the freezer between use |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *To maximize shelf-life, keep Opti-Tatt in the freezer between use |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 40 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00714646001009 [Primary] |
| GS1 | 00714646001108 [Unit of Use] |
FDA Product Code
| FZZ | MARKER, SKIN |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-20 |
| Device Publish Date | 2023-06-12 |
Devices Manufactured by Bionix, LLC
| 10714646000542 - Lighted Ear Curette Demo Pack | 2024-07-18 Lighted Ear Curette Demo Pack |
| 00714646000552 - Sample, Lighted FlexLoop | 2024-07-18 Sample, Lighted FlexLoop |
| 10714646000566 - Sample, Safe Ear Curette Rainbow Pack | 2024-07-18 Sample, Safe Ear Curette Rainbow Pack |
| 10714646000641 - Lighted Ear Curette Demo Pack (monthly mailer) | 2024-07-18 Lighted Ear Curette Demo Pack (monthly mailer) |
| 00714646001085 - Sample, Lighted Suction Handle | 2024-07-18 Sample, Lighted Suction Handle |
| 00714646001252 - Lighted Articulating - Sample | 2024-06-24 Lighted Articulating Curette - Sample |
| 10714646001198 - SecureFoam | 2024-06-10 SecureFoam - Small |
| 10714646001204 - SecureFoam | 2024-06-10 SecureFoam - Medium |
Trademark Results [Opti-Tatt]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OPTI-TATT 97815523 not registered Live/Pending |
Bionix, LLC 2023-02-28 |
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