FDA UDI
In Commercial Distribution
🇺🇸 United States
Barbed broaches 31mm 025-040, pu: 12 p
DI: 07630049992429
·
Model: 425031.2540
·
Diaswiss SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Barbed broaches 31mm 025-040, pu: 12 p
- Primary DI
- 07630049992429
- Version / Model
- 425031.2540
- Company Name
- Diaswiss SA
- Labeler DUNS
- 480296552
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-01
- Public Version
- 1
- Public Version Date
- 2023-12-11
- Public Version Status
- New
- Public Device Record Key
- 45c9bff4-f25c-42b7-a1cf-cb8c02263a3a
Device Description
Manual instrument for endodontic intraoral use
Device Characteristics
- Single Use
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| EKW | BROACH, ENDODONTIC | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35784 | Endodontic broach, serrated, reusable | A hand-held, manual, dental, cutting instrument with a slender, tapered, serrated/barbed tip intended to be used for shaping and enlarging holes in root canal tissue, particularly dentine, or for extirpating pulp. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07630049992429 | GS1 |