FDA UDI
In Commercial Distribution
🇺🇸 United States
Sterile, Single Use, ICL Forceps, 20G
DI: 05404027417042
·
Model: 651072
·
Hasa Optix
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- Sterile, Single Use, ICL Forceps, 20G
- Primary DI
- 05404027417042
- Version / Model
- 651072
- Company Name
- Hasa Optix
- Labeler DUNS
- 371290408
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2023-11-23
- Public Version
- 1
- Public Version Date
- 2023-12-01
- Public Version Status
- New
- Public Device Record Key
- 304a981d-38a0-4c8f-bbab-0beabc320053
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 05404027402215 | GS1 | ||||
| Primary | 05404027417042 | GS1 |
Customer Contacts
- Phone
- +32025246388
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry; Keep away form the sunlight, storage temperature 0-40°C,