FDA UDI
In Commercial Distribution
🇺🇸 United States
Boston Scientific
DI: 06921865500020
·
Model: SMG-218-2000
·
Jianerkang Medical Co., Ltd
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2000
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Boston Scientific
- Primary DI
- 06921865500020
- Version / Model
- SMG-218-2000
- Company Name
- Jianerkang Medical Co., Ltd
- Labeler DUNS
- 530968767
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2000
- Record Status
- Published
- Publish Date
- 2020-11-06
- Public Version
- 4
- Public Version Date
- 2022-11-28
- Public Version Status
- Update
- Public Device Record Key
- b788c6a1-0367-40c3-b1fd-62da64e249f3
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NAB | Gauze / Sponge,Nonresorbable For External Use | General, Plastic Surgery | 878.4014 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60796 | General-body orifice lubricant | A substance intended to facilitate entry of a diagnostic or therapeutic device into a body orifice by reducing friction between the device and the body; it is not dedicated to a particular part of the anatomy. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 26921865500000 | GS1 | ||||
| Primary | 06921865500020 | GS1 |