FDA UDI
In Commercial Distribution
🇺🇸 United States
AccuPak, Accurus, Alcon
DI: 00380657502479
·
Model: 8065750247
·
Alcon Laboratories, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- AccuPak, Accurus, Alcon
- Primary DI
- 00380657502479
- Version / Model
- 8065750247
- Company Name
- Alcon Laboratories, Inc.
- Labeler DUNS
- 008018525
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 576b97d9-b42b-49bd-9ac5-ec102fecd81d
Device Description
AccuPak Convertible Irrigation/Aspiration Tubing Set
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
- Yes
- 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 |
|---|---|---|---|---|
| HQC | Unit, phacofragmentation | Ophthalmic | 886.4670 | 2 |
| HQE | Instrument, vitreous aspiration and cutting, ac-powered | Ophthalmic | 886.4150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45185 | Ultrasonic surgical system tubing set | A sterile collection of dual-lumen tubing and connectors that are used in an ultrasonic surgical system to transport irrigation fluid through one lumen to the surgical site, and remove the aspirate through the other for collection in a suction bottle/canister. The tubing connects to the system's generator at one end and will typically be fitted with safety connectors; it is used only with systems that include irrigation/aspiration. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10380657502476 | GS1 | Box | 6 | In Commercial Distribution | |
| Primary | 00380657502479 | GS1 |
Customer Contacts
- Phone
- +1(800)862-5266
- [email protected]