FDA UDI
In Commercial Distribution
🇺🇸 United States
MesireTM Illuminus - Sinus Light Wire
DI: 18904224901541
·
Model: MSI083
·
MERIL LIFE SCIENCES PRIVATE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MesireTM Illuminus - Sinus Light Wire
- Primary DI
- 18904224901541
- Version / Model
- MSI083
- Catalog Number
- MSI083
- Company Name
- MERIL LIFE SCIENCES PRIVATE LIMITED
- Labeler DUNS
- 650328680
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-05-30
- Public Version
- 3
- Public Version Date
- 2018-10-05
- Public Version Status
- Update
- Public Device Record Key
- e8d5a2f2-23cb-496c-a6de-d8d4926a291a
Device Description
MesireTM Illuminus -Sinus Light Wire, 0.83 mm
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LRC | Instrument, Ent Manual Surgical | Ear, Nose, Throat | 874.4420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48144 | Paranasal sinus-illumination light guide cable | A sterile device designed to transmit cold light via a guidewire into the sinus cavities to provide illumination of the operative site during diagnostic and therapeutic procedures in conjunction with other nasal and sinus devices. It is typically a flexible light cable with a fibreoptic core which tapers at the distal end into a long, thin, probe that is capable of being manoeuvred into the various cavities; the proximal end will attach to an appropriate light source. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 18904224901541 | GS1 |
Customer Contacts
- Phone
- +1 (609) 951 2287
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K172737 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 0.83 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at or below 40°C; temperature