FDA UDI
In Commercial Distribution
🇺🇸 United States
Sterile,Single Use,Capsulorhexis Forceps,Curved Thin Shafts Round Knurled Handle
DI: 05404027400280
·
Model: 651141
·
Hasa Optix
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- Sterile,Single Use,Capsulorhexis Forceps,Curved Thin Shafts Round Knurled Handle
- Primary DI
- 05404027400280
- Version / Model
- 651141
- Company Name
- Hasa Optix
- Labeler DUNS
- 371290408
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2023-11-13
- Public Version
- 1
- Public Version Date
- 2023-11-21
- Public Version Status
- New
- Public Device Record Key
- 95f64d53-b223-43f9-bb58-fa76e760b2eb
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 |
|---|---|---|---|---|
| 62673 | Ophthalmic soft-tissue manipulation forceps, tweezers-like, single-use | A sterile, hand-held manual surgical instrument designed to facilitate grasping, manipulation or clamping of, and/or removal of foreign bodies from, ophthalmic soft-tissues (ocular tissues, eyelids), and may be pointed for capsulorhexis. It has a conventional (self-opening) or reverse-action (self-closing) tweezers-like design, with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles); it is not probe-like in design (i.e., not cannulated). It is typically made of metal, available in various sizes, and may have carbide inserts at the working end. 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 | 05404027415116 | GS1 | ||||
| Primary | 05404027400280 | 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,