Identity
- Trade Name
- Stryker FDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed FDA UDI
- Model / Reference
- E1035 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B504CBE10350 FDA UDI
- 510(k) Number
- K172647 FDA UDI
- FDA Product Code
- NUJ FDA UDI
- GMDN Term
- Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Stryker by Provision — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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 II | Pending data |
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Manufacturer
- Manufacturer
- Provision
Sources (1)
- FDA UDI 8087ae12-7618-431c-bd9b-bfbea6882efd 36 fields · synced May 31, 2026