Identity
- Trade Name
- Self-Righting Needle Holder FDA UDI
- Generic Name
- Endoscopic electromechanical surgical system FDA UDI
- Model / Reference
- 20-30-077-01 FDA UDI
Identifiers
- Catalog Number
- 20-30-077-01 FDA UDI
- Primary DI / UDI-DI
- 07290017376196 FDA UDI
- 510(k) Number
- K223718 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Endoscopic electromechanical surgical system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Endoscopic electromechanical surgical system
Self-Righting Needle Holder by Human Xtensions , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic electromechanical surgical system.
- Anovo Surgeon Console — MOMENTIS SURGICAL LTD · Class II
- Anovo Surgeon Console and Anovo Power cable — MOMENTIS SURGICAL LTD · Class II
- Anovo Surgical System (Surgeon Console, RCU and cables) — MOMENTIS SURGICAL LTD · Class II
- Control handle — Dex Surgical · Class II
- Monopolar protection sleeve — Dex Surgical · Class II
- Control Unit — Dex Surgical · Class II
- Control Handle Left — Dex Surgical · Class II
- Arm Monopolar hook — Dex Surgical · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Human Xtensions , Ltd.
Sources (1)
- FDA UDI 452c7125-cefd-466c-a913-b81f2483da93 34 fields · synced May 31, 2026