FDA UDI
In Commercial Distribution
🇺🇸 United States
OtoSight Speculum Tip Combination Package
DI: 00850013784110
·
Model: Combo
·
Photonicare, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OtoSight Speculum Tip Combination Package
- Primary DI
- 00850013784110
- Version / Model
- Combo
- Company Name
- Photonicare, Inc.
- Labeler DUNS
- 078873691
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-04-15
- Public Version
- 1
- Public Version Date
- 2022-04-25
- Public Version Status
- New
- Public Device Record Key
- d178ba4e-a2a6-40ef-8d6d-73ed98bda8b0
Device 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).
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QJG | Device System, Imaging, Tympanic Membrane And Middle Ear | Radiology | 892.1560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34897 | Ear speculum, single-use | A semi-rigid or rigid, plastic or metal tube that is cone-shaped (i.e., it tapers down from a standard instrument fitting size to a small opening) and is either hand-held and manually inserted, or fitted onto a compatible otoscope, and then inserted into the ear canal to create a channel for examination, suction, irrigation, or the insertion of another surgical device during an ear/nose/throat (ENT) procedure. It may be referred to as an ear cannula. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850013784110 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191804 | 000 |