FDA UDI
In Commercial Distribution
🇺🇸 United States
Opti-Tatt™ Crosshairs
DI: 00714646001009
·
Model: UTRT-4200
·
Bionix, LLC
Product Codes
1
GMDN Terms
2
Identifiers
2
Pkg Device Count
24
Basic Information
- Brand Name
- Opti-Tatt™ Crosshairs
- Primary DI
- 00714646001009
- Version / Model
- UTRT-4200
- Catalog Number
- UTRT-4200
- Company Name
- Bionix, LLC
- Labeler DUNS
- 117844489
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 24
- Record Status
- Published
- Publish Date
- 2023-06-12
- Public Version
- 3
- Public Version Date
- 2023-08-11
- Public Version Status
- Update
- Public Device Record Key
- 55e44289-a9a5-41f8-a286-57701b2331a3
Device Description
Opti-Tatt, Crosshair, Sheet of 24
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FZZ | MARKER, SKIN | General, Plastic Surgery | 878.4660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61577 | Skin marking sticker | A hypoallergenic adhesive device (sticker) intended to be affixed to a patient’s skin (e.g., forehead) as a point of reference (marker), typically for use with external diagnostic imaging techniques. This is a single-use device. | No | Active |
| 62057 | Skin marking transfer paper | A non-sterile, noninvasive device intended to transfer a grid of ink dots onto the skin surface to assist a clinical procedure, such as accurate subcutaneous injection spacing. It is a non-latex transfer paper designed to be applied to the skin and then peeled away to leave the ink dots, which are subsequently removed from the skin (e.g., with alcohol) after the procedure. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00714646001108 | GS1 | ||||
| Primary | 00714646001009 | GS1 |
Customer Contacts
- Phone
- +1(800)551-7096
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- To maximize shelf-life, keep Opti-Tatt in the freezer between use
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 40 Degrees Fahrenheit