FDA UDI
In Commercial Distribution
🇺🇸 United States
Alcon Grieshaber
DI: 07612717069275
·
Model: 617.92
·
Alcon Laboratories, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Alcon Grieshaber
- Primary DI
- 07612717069275
- Version / Model
- 617.92
- Company Name
- Alcon Laboratories, Inc.
- Labeler DUNS
- 008018525
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-19
- Public Version
- 1
- Public Version Date
- 2020-08-27
- Public Version Status
- New
- Public Device Record Key
- a14b60cc-b0e3-4bd0-a4df-f26e8cf53c10
Device Description
Sclerotomy Adapter 20/25G, DSP
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
- 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 |
|---|---|---|---|---|
| NGY | Cannula, trocar, ophthalmic | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47365 | Ophthalmic working-channel cannula, single-use | A sterile rigid tube designed to create a channel through the sclera for internal ocular access during posterior segment ophthalmic surgery. It is typically made of plastic materials or high-grade stainless steel and enables the introduction of ophthalmic surgical instruments; it may also be used for irrigation (i.e., the infusion of fluids to maintain the interior pressure of the eye during surgery). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 17612717069272 | GS1 | 6 | In Commercial Distribution | ||
| Primary | 07612717069275 | GS1 |
Customer Contacts
- Phone
- +1(800)862-5266
- [email protected]