FDA UDI
In Commercial Distribution
🇺🇸 United States
Pro-Paks
DI: 10810003224344
·
Model: 221102B
·
MICROSPECIALITIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- Pro-Paks
- Primary DI
- 10810003224344
- Version / Model
- 221102B
- Company Name
- MICROSPECIALITIES, INC.
- Labeler DUNS
- 013469890
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2022-12-11
- Public Version
- 1
- Public Version Date
- 2022-12-19
- Public Version Status
- New
- Public Device Record Key
- f7aaa64d-0b7a-46a1-94bf-5de2eeae31de
Device Description
Ophthalmic pack. PRO-PAKS Personalized Eye Tray Systems offer the best option for Surgical Packs and a Systematized approach combined with the Personal Touch. PRO-PAKS personalized procedure trays offers a fully custom pack, from EXACT components to EXACT quantities and the ability to adapt the sequence of which the individual items are placed in the pack.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| OJK | Eye Tray | Ophthalmic | 886.4790 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45150 | Ophthalmic surgical procedure kit, non-medicated, single-use | A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any pharmaceuticals. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00810003224347 | GS1 | ||||
| Primary | 10810003224344 | GS1 |
Customer Contacts
- Phone
- 203-874-1832
- [email protected]