Surgical Kit
- Primary DI
- 08806343900548
- Brand
- Surgical Kit
- Company
- Shinhung MST Co., Ltd.
- Model
- SSD4011A
- Device description
- These Drills are surgical tools that are used to expect the direction and place of implant, to measure the drilling hole depth and gingival height for selecting abutments according to gingival heights and to insert the implant in prepared implant site after drilling for preparation of the site of dental implants, to successful Crestal Approach Sinus operation by cutting sinus floor promptly and lifting up the Sinus Membrane safely.
- Published
- 2020-07-02
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| DZA | Drill, Dental, Intraoral |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| DZA | Drill, Dental, Intraoral | Dental | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 08806343900548 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 08806343900548 | 08806343900548 | 8806343900548 |
GMDN Terms
| Term | Definition |
|---|
| General/plastic surgical procedure kit, non-medicated, single-use | A collection of various sterile surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | 1 Degrees Celsius | 30 Degrees Celsius | |
Sterilization Methods
| Method |
|---|
| Dry Heat Sterilization |
| Moist Heat or Steam Sterilization |
Contacts
| Phone | Email |
|---|
| +82337301900 | syangt8823@shinhung.co.kr |
Regulatory Flags
- DUNS number
- 689667152
- 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
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 08800341415158 | First Drill | ARUM DENTISTRY Co., Ltd. | DZA | 2026-03-24 |
| 08800341415165 | Final Drill | ARUM DENTISTRY Co., Ltd. | DZA | 2026-03-24 |
| 08800341415172 | Final Drill | ARUM DENTISTRY Co., Ltd. | DZA | 2026-03-24 |
| 08800341415189 | Final Drill | ARUM DENTISTRY Co., Ltd. | DZA | 2026-03-24 |
| 08800341415196 | Final Drill | ARUM DENTISTRY Co., Ltd. | DZA | 2026-03-24 |
| 08800341415202 | Final Drill | ARUM DENTISTRY Co., Ltd. | DZA | 2026-03-24 |
| 08800341415219 | Final Drill | ARUM DENTISTRY Co., Ltd. | DZA | 2026-03-24 |
| 08800341415226 | Final Drill | ARUM DENTISTRY Co., Ltd. | DZA | 2026-03-24 |
| 08800341415233 | Final Drill | ARUM DENTISTRY Co., Ltd. | DZA | 2026-03-24 |
| 08800341415240 | Final Drill | ARUM DENTISTRY Co., Ltd. | DZA | 2026-03-24 |
| 08800341415257 | Final Drill | ARUM DENTISTRY Co., Ltd. | DZA | 2026-03-24 |
| 08800341415264 | Final Drill | ARUM DENTISTRY Co., Ltd. | DZA | 2026-03-24 |
| 08800341415271 | Final Drill | ARUM DENTISTRY Co., Ltd. | DZA | 2026-03-24 |
| 08800055792163 | Step Drill | ARUM DENTISTRY Co., Ltd. | DZA | 2026-03-20 |
| 08800055792170 | Step Drill | ARUM DENTISTRY Co., Ltd. | DZA | 2026-03-20 |
| 08800055792187 | Step Drill | ARUM DENTISTRY Co., Ltd. | DZA | 2026-03-20 |
| 08800055792194 | Step Drill | ARUM DENTISTRY Co., Ltd. | DZA | 2026-03-20 |
| 08800055792200 | Step Drill | ARUM DENTISTRY Co., Ltd. | DZA | 2026-03-20 |
| 08800055792217 | Step Drill | ARUM DENTISTRY Co., Ltd. | DZA | 2026-03-20 |
| 08800055792224 | Step Drill | ARUM DENTISTRY Co., Ltd. | DZA | 2026-03-20 |
| 08800055792231 | Step Drill | ARUM DENTISTRY Co., Ltd. | DZA | 2026-03-20 |
| 08800055792248 | Step Drill | ARUM DENTISTRY Co., Ltd. | DZA | 2026-03-20 |
| 08800055792255 | Step Drill | ARUM DENTISTRY Co., Ltd. | DZA | 2026-03-20 |
| 08800055792262 | Step Drill | ARUM DENTISTRY Co., Ltd. | DZA | 2026-03-20 |
| 08800055792279 | Step Drill | ARUM DENTISTRY Co., Ltd. | DZA | 2026-03-20 |
| 08800055792286 | Step Drill | ARUM DENTISTRY Co., Ltd. | DZA | 2026-03-20 |
| 08800055792293 | Step Drill | ARUM DENTISTRY Co., Ltd. | DZA | 2026-03-20 |
| 08800055792309 | Step Drill | ARUM DENTISTRY Co., Ltd. | DZA | 2026-03-20 |
| 08800055792316 | Step Drill | ARUM DENTISTRY Co., Ltd. | DZA | 2026-03-20 |
| 08800055792323 | Step Drill | ARUM DENTISTRY Co., Ltd. | DZA | 2026-03-20 |