FDA UDI
In Commercial Distribution
🇺🇸 United States
Sterile,Single Use,Kelman-Mcpherson LensForceps,Angled Shafts,Flat Handle,105mm
DI: 05404027417004
·
Model: 551199
·
Hasa Optix
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- Sterile,Single Use,Kelman-Mcpherson LensForceps,Angled Shafts,Flat Handle,105mm
- Primary DI
- 05404027417004
- Version / Model
- 551199
- Company Name
- Hasa Optix
- Labeler DUNS
- 371290408
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2024-07-22
- Public Version
- 1
- Public Version Date
- 2024-07-30
- Public Version Status
- New
- Public Device Record Key
- 91fa2d7a-23c5-48de-a1aa-a00945ee95cb
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 |
|---|---|---|---|---|
| 47871 | Intraocular lens folder | A hand-held, sterile, device designed to uniformly fold a foldable intraocular lens (IOL) in order to reduce its natural physical size so that the IOL can be removed from the IOL folder with an implantation forceps and be implanted into the anterior or posterior chamber of the eye through a small incision during ophthalmic surgery. It is typically made of synthetic material (e.g., polypropylene) and is designed to accept the IOL in its natural unfolded state, when in place the operator activates the folding mechanism. 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 | 05404027402178 | GS1 | ||||
| Primary | 05404027417004 | GS1 |
Customer Contacts
- Phone
- +32025246388
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry; Keep away form the sunlight, storage temperature 0-40°C,
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius