FDA UDI
Not in Commercial Distribution
🇺🇸 United States
MICHEL RHINOSCOPIC MIRROR
DI: 00192896094505
·
Model: 502-202
·
SONTEC INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MICHEL RHINOSCOPIC MIRROR
- Primary DI
- 00192896094505
- Version / Model
- 502-202
- Catalog Number
- 502-202
- Company Name
- SONTEC INSTRUMENTS, INC.
- Labeler DUNS
- 040729840
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-05-03
- Public Version
- 2
- Public Version Date
- 2019-05-29
- Public Version Status
- Update
- Public Device Record Key
- 5e17bfc6-1b9c-40f5-9f81-cccc3067ddae
- Distribution End Date
- 2019-05-28
Device Description
MICHEL RHINOSCOPIC MIRROR #2
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- 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
- Yes
- Sterilization Methods
- ["Moist Heat or Steam Sterilization", "Dry Heat Sterilization"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KAI | Mirror, Ent | Ear, Nose, Throat | 874.4420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38744 | Rhinoscopic mirror | A hand-held surgical instrument with a mirror or a surface sufficiently polished to reflect enough undiffused light to form a virtual image of an object placed before it at the distal end used for a rhinoscopic examination. The mirror is affixed to a very long, slender shaft with a handle at the proximal end that is held by the doctor who can manipulate the mirror close to the site of interest in the nose. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00192896094505 | GS1 |
Customer Contacts
- Phone
- 800-821-7496
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 16 | Millimeter |