FDA UDI
In Commercial Distribution
🇺🇸 United States
K.T.Surgico
DI: KTS0025716
·
Model: 2024
·
K.T.SURGICO
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
Basic Information
- Brand Name
- K.T.Surgico
- Primary DI
- KTS0025716
- Version / Model
- 2024
- Catalog Number
- KTS0025716
- Company Name
- K.T.SURGICO
- Labeler DUNS
- 645493024
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2024-07-24
- Public Version
- 1
- Public Version Date
- 2024-08-01
- Public Version Status
- New
- Public Device Record Key
- e34183fc-442e-493d-b106-1a500d2dc982
- Distribution End Date
- 2031-11-30
Device Description
Otoscope
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ERA | Otoscope | Ear, Nose, Throat | 874.4770 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12849 | Otoscope, direct | An electrically-powered, hand-held device designed for examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening. It consists of a main unit (commonly referred to as the head) with a built-in light source intended to illuminate the interior of the ear canal with a detachable cone-shaped tube (speculum) inserted in the ear canal; it may facilitate the application of air pressure for pneumatic otoscopy. A dedicated power supply handpiece and/or an insufflation bulb may be included with the head. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | MASTER90 | HIBCC | Master Box | 50 | Not in Commercial Distribution | 2024-07-21 |
| Unit of Use | TMS1332504 | HIBCC | ||||
| Primary | KTS0025716 | HIBCC |
Customer Contacts
- Phone
- 630-279-5000
- [email protected]