Identity
- Trade Name
- Aptra FDA UDI
- Generic Name
- Flexible video cystoscope, single-use FDA UDI
- Device Name
- Aptra Single-Use Digital Flexible Cystoscope FDA UDI
- Model / Reference
- BDCYSD01 FDA UDI
- Description
- Aptra Single-Use Digital Flexible Cystoscope FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850023925381 FDA UDI
- FDA Product Code
- FAJ FDA UDI
- GMDN Term
- Flexible video cystoscope, single-use 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Flexible video cystoscope, single-use
Aptra by Otu Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible video cystoscope, single-use.
- Single-Use Flexible Cystoscope — Hunan Vathin Medical Instrument Co., Ltd · Class II
- VersaVue Tablet - Global/CE Demo — MEDIMAGING INTEGRATED SOLUTION INC. · Class II
- Single-Use Flexible Cystoscope — Hunan Vathin Medical Instrument Co., Ltd · Class II
- Single-Use Flexible Cystoscope — Hunan Vathin Medical Instrument Co., Ltd · Class II
- Single-Use Flexible Cystoscope — Hunan Vathin Medical Instrument Co., Ltd · Class II
- Prosurg — Prosurg, Inc · Class II
- Prosurg — Prosurg, Inc · Class II
- Uro-G Flexible Cystoscope — UroViu Corporation · Class II
Cleared under the same submission
K212202 also covers:
K231702 also covers:
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
- Otu Medical Inc.
Sources (1)
- FDA UDI 1b057fdf-ab0b-4d8b-bad7-03752729e1e7 34 fields · synced May 30, 2026