FDA UDI
In Commercial Distribution
🇺🇸 United States
CANCELLO-PURE
DI: 00889797015363
·
Model: 46660200
·
WRIGHT MEDICAL TECHNOLOGY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CANCELLO-PURE
- Primary DI
- 00889797015363
- Version / Model
- 46660200
- Catalog Number
- 46660200
- Company Name
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Labeler DUNS
- 807201207
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-17
- Public Version
- 4
- Public Version Date
- 2022-08-10
- Public Version Status
- Update
- Public Device Record Key
- 8575449b-84fa-4c1d-81e8-9a987e8e1807
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| FZX | Guide, surgical, instrument | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61917 | Osteotomy guide, reusable | A surgical instrument intended to be attached to a bone (e.g., pelvis, femur, tibia, ulna) during an osteotomy procedure (including during joint arthroplasty) to outline/define the desired cut-line and mechanically support/guide the cutting device (e.g., oscillating cutting saw). This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00889797015363 | GS1 |
Customer Contacts
- Phone
- +1(800)238-7117
- [email protected]