FDA UDI
In Commercial Distribution
🇺🇸 United States
Alcon Grieshaber
DI: 07612717071377
·
Model: 339.21
·
Alcon Laboratories, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Alcon Grieshaber
- Primary DI
- 07612717071377
- Version / Model
- 339.21
- Company Name
- Alcon Laboratories, Inc.
- Labeler DUNS
- 008018525
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-22
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 04849805-6613-40b1-ab87-7fa52696de0e
Device Description
Diathermy Probe DSP, 25G
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
- 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 |
|---|---|---|---|---|
| HQC | Unit, Phacofragmentation | Ophthalmic | 886.4670 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62403 | Ophthalmic electrosurgical probe | A sterile, hand-held, ophthalmic surgical instrument intended to be introduced through the eye surface to deliver radio-frequency current, in a bipolar configuration, from a system generator directly to ocular tissues for blood coagulation and/or tissue adhesion during ophthalmic surgery. It includes a distal bipolar electrode and may include a connection cable. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 17612717071374 | GS1 | Box | 6 | In Commercial Distribution | |
| Primary | 07612717071377 | GS1 |
Customer Contacts
- Phone
- +18008625266
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 25 | Gauge |