Calamus
- Primary DI
- D716PACKHAND1
- Brand
- Calamus
- Company
- TULSA DENTAL PRODUCTS LLC
- Model
- PACKHAND
- Catalog number
- PACKHAND
- Device description
- Pack Handpiece For Dual
- Published
- 2022-10-17
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Related Records
Product Codes
| Code | Name |
|---|---|
| EKM | GUTTA-PERCHA |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| EKM | Gutta-Percha | Dental | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| D716PACKHAND1 | Primary | HIBCC | 0 |
GMDN Terms
| Term | Definition |
|---|---|
| Dental laboratory drilling system handpiece | A hand-held device that includes a chuck for attaching drills, burs, grind wheels, and similar rotating devices used in the dental laboratory. The device is typically remote from the power source (e.g., a dental laboratory drill motor) and is connected to this by a flexible drive system, which may be a Bowden cable. This is a reusable device. |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 942778564
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| D716PUENDO11 | ProUltra | PUENDO1 | PUENDO1 | 2016-10-07 |
| D716PUENDO151 | ProUltra | PUENDO1-5 | PUENDO1-5 | 2016-11-11 |
| D716PUENDO21 | ProUltra | PUENDO2 | PUENDO2 | 2016-10-07 |
| D716PUENDO31 | ProUltra | PUENDO3 | PUENDO3 | 2016-10-07 |
| D716PUENDO41 | ProUltra | PUENDO4 | PUENDO4 | 2016-10-07 |
| D716PUENDO51 | ProUltra | PUENDO5 | PUENDO5 | 2016-10-07 |
| D716PUENDO61 | ProUltra | PUENDO6 | PUENDO6 | 2016-10-07 |
| D716PUENDO681 | ProUltra | PUENDO6-8 | PUENDO6-8 | 2016-11-11 |
| D716PUENDO71 | ProUltra | PUENDO7 | PUENDO7 | 2016-10-07 |
| D716PUENDO81 | ProUltra | PUENDO8 | PUENDO8 | 2016-10-07 |
| D716PUSINE11 | ProUltra | PUSINE1 | PUSINE1 | 2016-10-07 |
| D716PUSINE161 | ProUltra SINE | PUSINE1-6 | PUSINE1-6 | 2016-11-11 |
| D716PUSINE21 | ProUltra | PUSINE2 | PUSINE2 | 2016-10-07 |
| D716PUSINE31 | ProUltra SINE | PUSINE3 | PUSINE3 | 2016-10-07 |
| D716PUSINE41 | ProUltra SINE | PUSINE4 | PUSINE4 | 2016-10-07 |
| D716PUSINE51 | ProUltra SINE | PUSINE5 | PUSINE5 | 2016-10-07 |
| D716PUSINE61 | ProUltra SINE | PUSINE6 | PUSINE6 | 2016-10-07 |
| D716PUSURG11 | ProUltra | PUSURG1 | PUSURG1 | 2016-10-07 |
| D716PUSURG161 | ProUltra | PUSURG1-6 | PUSURG1-6 | 2016-11-11 |
| D716PUSURG21 | ProUltra | PUSURG2 | PUSURG2 | 2016-10-07 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 06978880221102 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221119 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221126 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221133 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221140 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221157 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221164 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221171 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221188 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221195 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221201 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221218 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221225 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221232 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221249 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221256 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221263 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221270 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221287 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221294 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221300 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221317 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221324 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221331 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221348 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221355 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221362 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221379 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221386 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221393 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |