FDA UDI
In Commercial Distribution
🇺🇸 United States
Sterile, Single Use, Ck Lasik Marker, Target Centre, 9,5mm Diameter
DI: 05404027424262
·
Model: 558001
·
Hasa Optix
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- Sterile, Single Use, Ck Lasik Marker, Target Centre, 9,5mm Diameter
- Primary DI
- 05404027424262
- Version / Model
- 558001
- 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
- 50bac5ea-e499-41c4-a4ed-63a89946a34b
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 |
|---|---|---|---|---|
| HMR | Marker, ocular | Ophthalmic | 886.4570 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64553 | Scleral marker, single-use | A manual instrument intended to be used to indent or imprint the surface of the sclera during an ophthalmic surgical or perioperative procedure. It is typically a hand-held instrument or a thimble-like device (placed on the end of a finger) and is made of metal (e.g., high-grade stainless steel) or synthetic polymer materials. Various types are available, including the Gass scleral marker that creates a minuscule indentation, the Awh scleral marker that creates parallel scored lines, and the Awh horseshoe design. The device is typically used for retinal detachment surgery. 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 | 05404027409436 | GS1 | ||||
| Primary | 05404027424262 | 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