FDA UDI
In Commercial Distribution
🇺🇸 United States
Artman Instruments
DI: D127FX1NSYHS461
·
Model: FX1NSYHS46
·
Wise Linkers, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Artman Instruments
- Primary DI
- D127FX1NSYHS461
- Version / Model
- FX1NSYHS46
- Catalog Number
- 1
- Company Name
- Wise Linkers, LLC
- Labeler DUNS
- 081170668
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-29
- Public Version
- 1
- Public Version Date
- 2023-04-06
- Public Version Status
- New
- Public Device Record Key
- 62b378f7-2589-41f1-8105-00c7fdc2ce2e
Device Description
Artman Braces Color Bands Multicolored Dental Orthodontic Ligature Ties 1040 PCS
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ECI | Band, Elastic, Orthodontic | Dental | 872.5410 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46338 | Orthodontic band material | A material typically supplied in the form of rolls, strips, or precut blanks with the attachments in place ready to be configured as orthodontic bands. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D127FX1NSYHS461 | HIBCC |