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Tru-Vu Mini Precise Laparoscopic Endoscope, 30 Degree 4mm x 30cm
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Tru-Vu Mini Precise Laparoscopic Endoscope, 30 Degree 4mm x 30cm FDA UDI
- Generic Name
- Rigid optical laparoscope FDA UDI
- Device Name
- An endoscope with a rigid inserted portionangulus iridocornealis for the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs. FDA UDI
- Model / Reference
- 5740B FDA UDI
- Description
- An endoscope with a rigid inserted portionangulus iridocornealis for the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs. FDA UDI
Identifiers
- Catalog Number
- 5740B FDA UDI
- Primary DI / UDI-DI
- 00848657075787 FDA UDI
- 510(k) Number
- K993688 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Rigid optical laparoscope 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
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Rigid optical laparoscope
Tru-Vu Mini Precise Laparoscopic Endoscope, 30 Degree 4mm x 30cm by National Advanced Endoscopy Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Rigid optical laparoscope.
- Laparoscope — SOPRO-COMEG GmbH · Class II
- ELMED — ELMED INCORPORATED · Class II
- Laparoscope — SOPRO-COMEG GmbH · Class II
- HOPKINS — Karl Storz GmbH & Co. KG · Class II
- MEDIVISION — MEDIVISION, INC. · Class II
- Laparoscope — SOPRO-COMEG GmbH · Class II
- CONMED — Conmed Corporation · Class II
- ELMED — ELMED INCORPORATED · Class II
Cleared under the same submission
K993688 also covers:
- 57810A AED 8mm x 0 Degree x 17cm Endoscope — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
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
- National Advanced Endoscopy Devices, Inc.
Sources (1)
- FDA UDI c0f61354-3ad1-45de-97c8-b05a96414036 36 fields · synced May 30, 2026