FDA UDI
In Commercial Distribution
🇺🇸 United States
Q.C.M.Retainer Wire
DI: 04570077940326
·
Model: RWL-W50
·
CHIKAMI MILTEC INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Q.C.M.Retainer Wire
- Primary DI
- 04570077940326
- Version / Model
- RWL-W50
- Company Name
- CHIKAMI MILTEC INC.
- Labeler DUNS
- 691622872
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-13
- Public Version
- 1
- Public Version Date
- 2021-08-23
- Public Version Status
- New
- Public Device Record Key
- 9fc8bef1-befc-4a1f-ac47-95f2052e70ce
Device Description
This product can be used to make a very aesthetic retainer called Q C M Retainer W The best feature of this product is that the resin part and the wire part are connected by screws so if the resin part gets dirty or damaged the resin part can be replaced
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
- No
- 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 |
|---|---|---|---|---|
| DZC | Wire, Orthodontic | Dental | 872.5410 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35310 | Orthodontic retainer | An orthodontic appliance, bonded or removable, intended to be used on a single patient to maintain teeth in corrected positions during the period of functional adaptation following corrective treatment. This appliance, also referred to as a positioner, is also used to maintain the positions of the teeth and jaws gained by orthodontic procedures. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04570077940326 | GS1 |