Identity
- Trade Name
- Boston Scientific FDA UDI
- Generic Name
- General-body orifice lubricant FDA UDI
- Model / Reference
- SMG-218-2000 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06921865500020 FDA UDI
- FDA Product Code
- NAB FDA UDI
- GMDN Term
- General-body orifice lubricant FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4014 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: General-body orifice lubricant
Boston Scientific by Jianerkang Medical Co., Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Jianerkang Medical Co., Ltd
Sources (1)
- FDA UDI b788c6a1-0367-40c3-b1fd-62da64e249f3 32 fields · synced May 31, 2026