FDA UDI
In Commercial Distribution
🇺🇸 United States
CyclaPlex Drill Bits 1.8-3.0
DI: 07290017626161
·
Model: V7
·
ALPHAMET LTD
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- CyclaPlex Drill Bits 1.8-3.0
- Primary DI
- 07290017626161
- Version / Model
- V7
- Catalog Number
- DB-9243
- Company Name
- ALPHAMET LTD
- Labeler DUNS
- 600372473
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-02-12
- Public Version
- 2
- Public Version Date
- 2020-05-19
- Public Version Status
- Update
- Public Device Record Key
- 5b461d3b-0e89-45c0-a223-52a469bae101
Device Description
The 1.8 and 3.0 mm quick coupling drill bits are intended to be used for implantation of CyclaPlex Implant.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HTN | Washer, Bolt Nut | Orthopedic | 888.3030 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47563 | Fluted surgical drill bit, single-use, non-sterile | A non-sterile shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, its shaft is mounted into a surgical power tool or a surgical hand drill/brace. This is a single-use device intended to be sterilized prior to use. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290017626161 | GS1 | ||||
| Package | 07290017626178 | GS1 | Box | 20 | In Commercial Distribution | |
| Package | 07290017626864 | GS1 | Packing box | 20 | In Commercial Distribution |
Customer Contacts
- Phone
- (260) 438-2198
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K183094 | 000 |