FDA UDI
In Commercial Distribution
🇺🇸 United States
Cusp-Lok
DI: D867CLIMCLP10
·
Model: IMCLP
·
Xemax Surgical Products Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- Cusp-Lok
- Primary DI
- D867CLIMCLP10
- Version / Model
- IMCLP
- Catalog Number
- CLIMC10LP
- Company Name
- Xemax Surgical Products Inc
- Labeler DUNS
- 804495695
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2022-09-09
- Public Version
- 1
- Public Version Date
- 2022-09-19
- Public Version Status
- New
- Public Device Record Key
- 88a22a6a-4f05-407f-a758-b9cf2901df76
Device Description
Orthodontic bracket with chain
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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EJF | Bracket, Metal, Orthodontic | Dental | 872.5410 | 1 |
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 |
|---|---|---|---|---|---|---|
| Unit of Use | D867CLIMCLP101 | HIBCC | ||||
| Primary | D867CLIMCLP10 | HIBCC |