Identity
- Trade Name
- OtoSight Speculum Tip Combination Package FDA UDI
- Generic Name
- Ear speculum, single-use FDA UDI
- Device Name
- Combination Package for shipping containing QTY 100 Large OtoSight Speculum Tips (Unit of Use DI #00850013784073) packaged in 5 20-packs (DI#10850013784070) and QTY 100 Standard OtoSight Speculum Tips (Unit of Use DI #00850013784080) packaged in 5 20-packs (DI#10850013784087). FDA UDI
- Model / Reference
- Combo FDA UDI
- Description
- Combination Package for shipping containing QTY 100 Large OtoSight Speculum Tips (Unit of Use DI #00850013784073) packaged in 5 20-packs (DI#10850013784070) and QTY 100 Standard OtoSight Speculum Tips (Unit of Use DI #00850013784080) packaged in 5 20-packs (DI#10850013784087). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850013784110 FDA UDI
- 510(k) Number
- K191804 FDA UDI
- FDA Product Code
- QJG FDA UDI
- GMDN Term
- Ear speculum, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ear speculum, single-use
OtoSight Speculum Tip Combination Package by Photonicare, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- Photonicare, Inc.
Sources (1)
- FDA UDI d178ba4e-a2a6-40ef-8d6d-73ed98bda8b0 34 fields · synced May 30, 2026