Identity
- Trade Name
- USA Elite FDA UDI
- Generic Name
- Rigid endoscope obturator FDA UDI
- Device Name
- USA Elite System Visual Urethrotome Standard Obturator 22 Fr (7.3 mm) FDA UDI
- Model / Reference
- EVUS-22-OB FDA UDI
- Description
- USA Elite System Visual Urethrotome Standard Obturator 22 Fr (7.3 mm) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821925003767 FDA UDI
- FDA Product Code
- EZO FDA UDI
- GMDN Term
- Rigid endoscope obturator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4770 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
Yes
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 endoscope obturator
USA Elite by Gyrus Acmi, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rigid endoscope obturator.
- Arthroscopy bridge — SOPRO-COMEG GmbH · Class II
- Biportal Laminoscope, ocular — Joimax GmbH · Class IIa
- TAUT — TELEFLEX INCORPORATED · Class II
- Hysteroscopy obturator — SOPRO-COMEG GmbH · Class II
- Spinal surgery spongiosa pushers — Richard Wolf GmbH · Class I
- Trabecular Metal® — Zimmer, Inc. · Class I
- SHARK — Richard Wolf GmbH · Class II
- Obturator — SOPRO-COMEG GmbH · 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
- Gyrus Acmi, Inc.
Sources (1)
- FDA UDI debd3aa3-9cd3-4c71-ac98-ce8bcf0dde33 33 fields · synced May 30, 2026