FDA UDI
In Commercial Distribution
🇺🇸 United States
Bone Cement Injection Gun
DI: 06938695501295
·
Model: SD8101
·
Shanghai Kinetic Medical Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Bone Cement Injection Gun
- Primary DI
- 06938695501295
- Version / Model
- SD8101
- Catalog Number
- SD8101
- Company Name
- Shanghai Kinetic Medical Co., Ltd.
- Labeler DUNS
- 528198569
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-07-20
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 43d4677f-f4c3-4a6e-b78e-f6b71d410181
Device Description
Bone Cement Injection Gun
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KIH | Dispenser, Cement | Orthopedic | 888.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45253 | Orthopaedic cement preparation/delivery kit | A collection of sterile surgical instruments, tools, and materials designed to prepare and apply bone cement during an orthopaedic surgical procedure (e.g., hip replacement, arthroplasty, or vertebroplasty). It typically includes items such as forceps, a mallet, cement delivery injectors, delivery tubes, and mixing devices; it may or may not include bone cement. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06938695501295 | GS1 |
Customer Contacts
- Phone
- +862150720558
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 18 – 25 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- – 80 Percent (%) Relative Humidity