FDA UDI
In Commercial Distribution
🇺🇸 United States
Barbed Broaches, 0-6, 21
DI: 05060940375311
·
Model: HSB21ASS2
·
ENDOPERFECTION LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Barbed Broaches, 0-6, 21
- Primary DI
- 05060940375311
- Version / Model
- HSB21ASS2
- Company Name
- ENDOPERFECTION LIMITED
- Labeler DUNS
- 224419290
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-12
- Public Version
- 1
- Public Version Date
- 2023-12-20
- Public Version Status
- New
- Public Device Record Key
- 27db31db-312a-4c4e-b458-01e06a732d25
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
- 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
- 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 | 05060940375311 | GS1 |