FDA UDI
In Commercial Distribution
🇺🇸 United States
ADITEK
DI: 07899439200036
·
Model: 14.00.0018
·
ADITEK DO BRASIL S/A
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ADITEK
- Primary DI
- 07899439200036
- Version / Model
- 14.00.0018
- Catalog Number
- 14.00.0018
- Company Name
- ADITEK DO BRASIL S/A
- Labeler DUNS
- 900761396
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-30
- Public Version
- 2
- Public Version Date
- 2024-05-16
- Public Version Status
- Update
- Public Device Record Key
- de91e995-68c2-4391-85e9-c78ee172e73f
Device Description
Box w/4 Kits 5x5 EasyClip+ Interactive 022 D Super Hk 3,4,5 w/Accessories
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46581 | Orthodontic bracket, metal | A metallic device that is bonded to an orthodontic band, or directly to a tooth, to hold an orthodontic wire and/or other appliance (e.g., rubber bands) used to apply pressure to the tooth in order to alter the position of the tooth. 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 |
|---|---|---|---|---|---|---|
| Primary | 07899439200036 | GS1 |