FDA UDI
In Commercial Distribution
🇺🇸 United States
PRO-PAKS®️
DI: 10810003220032
·
Model: MK-108
·
MICROSPECIALITIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
Basic Information
- Brand Name
- PRO-PAKS®️
- Primary DI
- 10810003220032
- Version / Model
- MK-108
- Catalog Number
- MK-108
- Company Name
- MICROSPECIALITIES, INC.
- Labeler DUNS
- 013469890
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2018-10-30
- Public Version
- 1
- Public Version Date
- 2018-11-30
- Public Version Status
- New
- Public Device Record Key
- 6c1bd462-563e-4b3d-8ba1-ad597e415612
Device Description
ULTRA Premium PVA Lasik Spear. Our effective synthetic PVA sponges and fluid management items are highly absorbent allowing aqueous solutions to be wicked up quickly. Our ULTRA PREMIUM Spears are 100% lint free. 15 Tyvek Pouches of 10 each (2 foils).
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|---|---|
| Package | 30810003220036 | GS1 | Box | 15 | In Commercial Distribution | |
| Primary | 10810003220032 | GS1 | ||||
| Unit of Use | 00810003220035 | GS1 |
Customer Contacts
- Phone
- 203-874-1832
- [email protected]