FDA UDI
In Commercial Distribution
🇺🇸 United States
Sterilized Eol Auto Lancet
DI: 08809262393422
·
Model: LBAL 28G
·
HLB CO.,LTD
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Basic Information
- Brand Name
- Sterilized Eol Auto Lancet
- Primary DI
- 08809262393422
- Version / Model
- LBAL 28G
- Company Name
- HLB CO.,LTD
- Labeler DUNS
- 987587913
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2025-08-20
- Public Version
- 1
- Public Version Date
- 2025-08-28
- Public Version Status
- New
- Public Device Record Key
- b74a99cd-2893-4700-8c88-1cf0ec1e5764
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | General, Plastic Surgery | 878.4850 | 2 |
| QRK | Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | General, Plastic Surgery | 878.4850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64579 | Fully-implantable middle ear implant system vibrator assembly | A component of a fully-implantable middle ear implant system that includes a vibrator tip which is coupled with an ossicle (middle ear bone). It receives electrical signals from the implanted sound processor/microphone (via wired connection), and converts the signals back to audio frequencies which are sent to the vibrator tip for the transmission of vibrations to the middle ear bones to activate the auditory pathway. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 08809262393880 | GS1 | ||||
| Primary | 08809262393422 | GS1 |
Customer Contacts
- Phone
- +82448629134
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K243533 | 000 |