FDA UDI
In Commercial Distribution
🇺🇸 United States
Eyetec
DI: 05056100712522
·
Model: 1-420B
·
NETWORK MEDICAL PRODUCTS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Eyetec
- Primary DI
- 05056100712522
- Version / Model
- 1-420B
- Company Name
- NETWORK MEDICAL PRODUCTS LIMITED
- Labeler DUNS
- 458670304
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-07-09
- Public Version
- 1
- Public Version Date
- 2021-07-19
- Public Version Status
- New
- Public Device Record Key
- e9e0edce-3d9f-4181-9e7c-7a573e900a39
Device Description
1-420B Corneal Light Shield Bulk Packed Non-sterile 8mm - 100 Glassines Per Bag
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
- 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 |
|---|---|---|---|---|
| HOZ | Sponge, Ophthalmic | Ophthalmic | 886.4790 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13704 | Ophthalmic sponge | A device made of absorbent material, e.g., gauze, cotton or cellulose, intended to be used to absorb excess fluid produced by the eye during microsurgical procedures and ophthalmic surgery such as cataract surgery and laser assisted in situ keratomileusis (LASIK) procedures. Some types can be used as an eyelid and lash guard and are typically shaped for use in conjunction with an eye speculum. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05056100712522 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K130117 | 000 |