FDA UDI
In Commercial Distribution
🇺🇸 United States
Calamus
DI: D716CALP1051
·
Model: CALP105
·
TULSA DENTAL PRODUCTS LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Calamus
- Primary DI
- D716CALP1051
- Version / Model
- CALP105
- Catalog Number
- CALP105
- Company Name
- TULSA DENTAL PRODUCTS LLC
- Labeler DUNS
- 942778564
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-09
- Public Version
- 1
- Public Version Date
- 2022-11-17
- Public Version Status
- New
- Public Device Record Key
- 951fb8b7-c8d2-4633-8d81-cf9520eb7b12
Device Description
CALAMUS PLUGGER: MANUAL 10.5
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
- 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 |
|---|---|---|---|---|
| EKR | PLUGGER, ROOT CANAL, ENDODONTIC | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41876 | Endodontic plugger | A hand-held, manually-operated, dental instrument specifically designed to compress filling materials in a root canal, mainly in an axial direction. The working distal end is cylindrical or tapered, circular in cross-section, and has a flat-tipped end. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D716CALP1051 | HIBCC |