FDA UDI
In Commercial Distribution
🇺🇸 United States
SSG10
DI: 08809260474994
·
Model: SSG10 #10
·
Saeshin Precision Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SSG10
- Primary DI
- 08809260474994
- Version / Model
- SSG10 #10
- Company Name
- Saeshin Precision Co., Ltd.
- Labeler DUNS
- 688019566
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-21
- Public Version
- 1
- Public Version Date
- 2025-05-29
- Public Version Status
- New
- Public Device Record Key
- 116a3869-04ed-448f-b2ab-1b5e1246155f
Device Description
BSG10/FUS12/MBP20SX/MBP20SX/TST20NN04/TST20NN04/TST20NN04/TST20NN04
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| HBC | Motor, Drill, Electric | Neurology | 882.4360 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66243 | Bone/joint surgical power tool motorized handpiece/set, electric, reusable | An electrically-powered one-piece device or modular device collection designed to accept an endpiece(s) [e.g., drill bit, saw blade, bur] for drilling, cutting, and/or inserting procedures involving bones and tough tissues during a surgical procedure; it is not dedicated to dental procedures. It includes an electric motor and typically one or more power tool attachments with a Jacobs chuck or quick-connect collet/adaptor at its distal end to connect the endpieces, and may include a rechargeable battery or a control unit; the endpieces are not included. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08809260474994 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K233153 | 000 |