FDA UDI
In Commercial Distribution
🇺🇸 United States
Alcon Grieshaber REVOLUTION
DI: 07612717070752
·
Model: 705.47
·
Alcon Laboratories, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Alcon Grieshaber REVOLUTION
- Primary DI
- 07612717070752
- Version / Model
- 705.47
- Company Name
- Alcon Laboratories, Inc.
- Labeler DUNS
- 008018525
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-18
- Public Version
- 1
- Public Version Date
- 2020-08-26
- Public Version Status
- New
- Public Device Record Key
- b23fe0f0-4609-4373-9647-f388a83c60d5
Device Description
REVOLUTION DSP 25G Serrated Forceps
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 |
|---|---|---|---|---|
| HNR | Forceps, ophthalmic | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62478 | Ophthalmic soft-tissue manipulation forceps, probe-like, single-use | A sterile, hand-held manual instrument designed to grasp and manipulate intraocular tissues during ophthalmic surgery (e.g., anterior segment surgery, vitreo-retinal procedures, iridectomy, capsulorhexis). It has a probe-like design with a proximal handle (typically cylindrical), a thin cannula-like shaft, and small grasping blades that protrude from the distal end of the shaft. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 17612717070759 | GS1 | 6 | In Commercial Distribution | ||
| Primary | 07612717070752 | GS1 |
Customer Contacts
- Phone
- +1(800)862-5266
- [email protected]