Identity
- Trade Name
- Direct Drive Laparoscopic Scissors System FDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
- Device Name
- Reusable Scissor Handle FDA UDI
- Model / Reference
- CB101 FDA UDI
- Description
- Reusable Scissor Handle FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00607915117375 FDA UDI
- FDA Product Code
- HET FDA UDI
- GMDN Term
- Endoscopic electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1720 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
Direct Drive Laparoscopic Scissors System by Applied Medical Resources Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic electrosurgical handpiece/electrode, monopolar, single-use.
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- Polyp Pak — US Endoscopy · Class II
- ZKSK — Beijing ZKSK Technology Co., Ltd · 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 |
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Manufacturer
- Manufacturer
- Applied Medical Resources Corp.
Sources (1)
- FDA UDI b08344b9-b775-473f-aea4-2ea046a95b4e 34 fields · synced May 31, 2026