FDA UDI
In Commercial Distribution
🇺🇸 United States
Twist Lancet(30G)
DI: 06949517008021
·
Model: LF-TL-30
·
Shandong Lianfa Medical Plastic Products CO.,LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
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Basic Information
- Brand Name
- Twist Lancet(30G)
- Primary DI
- 06949517008021
- Version / Model
- LF-TL-30
- Company Name
- Shandong Lianfa Medical Plastic Products CO.,LTD
- Labeler DUNS
- 421330121
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2024-11-01
- Public Version
- 1
- Public Version Date
- 2024-11-11
- Public Version Status
- New
- Public Device Record Key
- 4387498f-9eb6-4016-95cf-53cb712b101c
Device Description
Sterile Lancet for Single Use (Box of 100 lancets), sterilized with Irradiation sterilization
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
- 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 |
|---|---|---|---|---|
| QRL | Multiple Use Blood Lancet For Single Patient Use Only | General, Plastic Surgery | 878.4850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61579 | Blood lancet, single-use | A sterile, hand-held, sharply-pointed, non-mechanical, scalpel-like instrument intended to be used by a healthcare provider to manually puncture the skin of a patient to obtain a small blood specimen or drain a cyst or boil. 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 | 56949517070887 | GS1 | ||||
| Primary | 06949517008021 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K222472 | 000 |