FDA UDI
In Commercial Distribution
🇺🇸 United States
Safescraper Twist
DI: 08056585230174
·
Model: 5532
·
META TECHNOLOGIES SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Safescraper Twist
- Primary DI
- 08056585230174
- Version / Model
- 5532
- Catalog Number
- 5532
- Company Name
- META TECHNOLOGIES SRL
- Labeler DUNS
- 442368394
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-25
- Public Version
- 1
- Public Version Date
- 2024-12-03
- Public Version Status
- New
- Public Device Record Key
- 5743023f-20bc-4693-8629-356fc8ff58a0
Device Description
SAFESCRAPER TWIST is a medical device intended for harvesting, collecting and releasing of autologous bone in regenerative applications in oral surgery.
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
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MXP | Bone Particle Collector | Ear, Nose, Throat | 874.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63815 | Bone collection scraper | A sterile, surgical device intended for the manual removal, through scraping, and collection of autogenous bone particles from a patient, typically as part of a dental surgical procedure. It consists of a handle with a scraping blade and a collection chamber. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08056585230174 | GS1 |
Customer Contacts
- Phone
- +390522502311
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 155.7 | Millimeter | |
| Height | 15.6 | Millimeter | |
| Width | 15.2 | Millimeter |