FDA UDI
In Commercial Distribution
🇺🇸 United States
QuickDraw
DI: 00850008316012
·
Model: 988-1200
·
PARADIGM BIODEVICES INC
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- QuickDraw
- Primary DI
- 00850008316012
- Version / Model
- 988-1200
- Company Name
- PARADIGM BIODEVICES INC
- Labeler DUNS
- 170751924
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-01
- Public Version
- 1
- Public Version Date
- 2019-07-09
- Public Version Status
- New
- Public Device Record Key
- 8cdf6e2d-5395-4782-ac78-9b2404f491e5
Device Description
QuickDraw Bone Harvester, 12mm
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 14147 | Bone trephine | An orthopaedic surgical blade designed to cut and remove circular sections of bone, typically for biopsy or percutaneous bone graft harvesting. It is typically a hollow cylinder with a circular, saw-like serrated working edge. It is an exchangeable device that may be attached to a manually-operated handle or to a powered rotary surgical handpiece. The device is typically made of high-grade stainless steel. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30850008316013 | GS1 | Box | 20 | In Commercial Distribution | |
| Package | 10850008316019 | GS1 | Box | 2 | In Commercial Distribution | |
| Primary | 00850008316012 | GS1 | ||||
| Package | 20850008316016 | GS1 | box | 5 | In Commercial Distribution |
Customer Contacts
- Phone
- 8886987778
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 230 | Millimeter | |
| Width | 12 | Millimeter |