Identity
- Trade Name
- GEN2 FDA UDI
- Generic Name
- Uterine probe FDA UDI
- Device Name
- Cohen Acorn Small Cone, Tube 3.24mm, TL 31.0mm OL 60mm(2 3/8") FDA UDI
- Model / Reference
- G2OB1569 FDA UDI
- Description
- Cohen Acorn Small Cone, Tube 3.24mm, TL 31.0mm OL 60mm(2 3/8") FDA UDI
Identifiers
- Catalog Number
- G2OB1569 FDA UDI
- Primary DI / UDI-DI
- 00840343722074 FDA UDI
- 510(k) Number
- K060233 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Uterine probe 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 2.325 Inch FDA UDI
Category: Uterine probe
Gen2 by Surgix Medical Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Uterine probe.
- Quinelato — Schobell Industrial Ltda · Class I
- American Medicals — AMERICAN MEDICALS · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- Gimmi — Gimmi GmbH · Class I
- Gimmi — Gimmi GmbH · Class I
- BR Surgical, LLC — BR SURGICAL LLC · Class I
- Vaginal Probe — CooperSurgical, Inc. · Class I
- V. Mueller — STERIS CORPORATION · Class I
Cleared under the same submission
K060233 also covers:
- Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY
- Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY
- Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY
- Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY
- Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY
- Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY
- Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY
- Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY
- Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY
- Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY
- Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY
- Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY
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
- Surgix Medical Llc
Sources (1)
- FDA UDI dbf0cb5a-ab10-4236-9674-d75eea4b23c2 37 fields · synced May 29, 2026