Identity
- Trade Name
- AED FDA UDI
- Generic Name
- Laparoscopic surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- Lap Suture Passer-Closure Forcep, 2.4mm, 15cm with Syringe Style Handle FDA UDI
- Model / Reference
- SP1600 FDA UDI
- Description
- Lap Suture Passer-Closure Forcep, 2.4mm, 15cm with Syringe Style Handle FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848657009652 FDA UDI
- FDA Product Code
- NWV FDA UDI
- GMDN Term
- Laparoscopic surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 884.1720 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Aed by National Advanced Endoscopy Devices, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- National Advanced Endoscopy Devices, Inc.
Sources (1)
- FDA UDI d86e4b3b-e92e-4b8c-ac29-2a0dd43013f3 34 fields · synced Jun 8, 2026