FDA UDI
In Commercial Distribution
🇺🇸 United States
Coronet
DI: 05060165012770
·
Model: 51-920
·
NETWORK MEDICAL PRODUCTS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Coronet
- Primary DI
- 05060165012770
- Version / Model
- 51-920
- Company Name
- NETWORK MEDICAL PRODUCTS LIMITED
- Labeler DUNS
- 458670304
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-08-29
- Public Version
- 5
- Public Version Date
- 2021-07-02
- Public Version Status
- Update
- Public Device Record Key
- 1ed7f98e-5990-4dcf-9e9d-ff1ace32cd9e
Device Description
Canaliculus Intubation Set
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| HRH | Trephine, Manual, Ophthalmic | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45358 | Corneal resection holder, single-use | A device designed to hold donated corneal tissue so that it can be resected in preparation for transplantation. The device may be in the form of a pedestal, with retention and locking rings, upon which the donated cornea is placed and inflated with air, or some other material, to simulate the pressure of the anterior chamber of the eye for the procedure. This method allows resection from the epithelial side of the cornea. The device may also include tubing and clips, and inflation is typically achieved manually with a syringe. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060165012770 | GS1 |