FDA UDI
In Commercial Distribution
🇺🇸 United States
MesireTM Guide - Sinus Guide Catheter
DI: 18904224901510
·
Model: MSG070
·
MERIL LIFE SCIENCES PRIVATE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MesireTM Guide - Sinus Guide Catheter
- Primary DI
- 18904224901510
- Version / Model
- MSG070
- Catalog Number
- MSG070
- 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
- fb95ec9a-e41e-4ed4-a4fe-0156aa195c4f
Device Description
MesireTM Guide - Sinus Guide Catheter, Angle 70°
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 |
|---|---|---|---|---|
| 48142 | Paranasal sinus guide-catheter | A sterile cannula-like catheter consisting of a tube with a tip designed to facilitate placement of other devices into or near different sinus ostia. It is used to provide a channel to access the sinus space during diagnostic and therapeutic procedures. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 18904224901510 | GS1 |
Customer Contacts
- Phone
- +1 (609) 951 2287
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K172737 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Angle | 70 | degree |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at or below 40°C; temperature