FDA UDI
In Commercial Distribution
🇺🇸 United States
UMarc
DI: 00860012076604
·
Model: OWS
·
New Venture Enterprise Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
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Basic Information
- Brand Name
- UMarc
- Primary DI
- 00860012076604
- Version / Model
- OWS
- Company Name
- New Venture Enterprise Ltd.
- Labeler DUNS
- 119292228
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2024-07-03
- Public Version
- 1
- Public Version Date
- 2024-07-11
- Public Version Status
- New
- Public Device Record Key
- cc0c77fa-20f4-480f-9f96-74d235e2f291
Device Description
Disposable Orthodontic Archwire Orange Markers
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EMP | Marker, Periodontic | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41397 | Orthodontic archwire | A dental wire in the shape of an arch used with orthodontic attachments (orthodontic brackets) that are affixed to the crowns/surfaces of two or more teeth in order to cause/guide tooth movement. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 10860012076601 | GS1 | ||||
| Primary | 00860012076604 | GS1 | ||||
| Package | 20860012076608 | GS1 | Case | 100 | In Commercial Distribution |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool, dry, well ventilated storage area away from direct sunlight. Do not store near oxidizing agents or strong acids.
- Type
- Storage Environment Temperature
- Temperature Range
- – 125 Degrees Fahrenheit