FDA UDI
In Commercial Distribution
🇺🇸 United States
Sterile,Single Use,Adjustable Speculum,Speculum,14mm Round Solid Blades,L 65mm
DI: 05404027427447
·
Model: 555028
·
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,Adjustable Speculum,Speculum,14mm Round Solid Blades,L 65mm
- Primary DI
- 05404027427447
- Version / Model
- 555028
- 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
- 95cf719c-b6ff-41a4-88d3-e75a064ca690
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 |
|---|---|---|---|---|
| HNC | Specula, ophthalmic | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46959 | Eyelid speculum, single-use | A self-retaining ophthalmic surgical instrument intended to be used to retract the eyelids during an ophthalmologic examination or procedure. It is typically composed of two arms joined at a pivot point and that terminate in blunt tips; the arms can be expanded with a self-opening or adjustable mechanism to stretch tissue. The device is available in various sizes, shapes, and contours. 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 | 05404027412610 | GS1 | ||||
| Primary | 05404027427447 | 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,