FDA UDI
In Commercial Distribution
🇺🇸 United States
LASIK Sponge
DI: 00813465011333
·
Model: 7305
·
HURRICANE MEDICAL INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Basic Information
- Brand Name
- LASIK Sponge
- Primary DI
- 00813465011333
- Version / Model
- 7305
- Catalog Number
- 7305
- Company Name
- HURRICANE MEDICAL INC
- Labeler DUNS
- 093377724
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2016-04-26
- Public Version
- 5
- Public Version Date
- 2020-04-14
- Public Version Status
- Update
- Public Device Record Key
- 84bf1c52-4a5c-4894-b975-93f1d0516251
Device Description
The LASIK sponge is used to absorb fluid from the surgical site during ophthalmic surgery.
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
- Yes
- Sterilization Methods
- ["Radiation Sterilization", "Ethylene Oxide"]
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 | 00813465011333 | GS1 | ||||
| Unit of Use | 10813465011330 | GS1 |
Customer Contacts
- Phone
- 9417510588
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K990671 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 2x4 mm |