FDA UDI
In Commercial Distribution
🇺🇸 United States
xinle
DI: 06950383616258
·
Model: XL-E 21G
·
Hebei Xinle Sci&Tech Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- xinle
- Primary DI
- 06950383616258
- Version / Model
- XL-E 21G
- Catalog Number
- XLE2118
- Company Name
- Hebei Xinle Sci&Tech Co., Ltd.
- Labeler DUNS
- 529813593
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2023-09-14
- Public Version
- 1
- Public Version Date
- 2023-09-22
- Public Version Status
- New
- Public Device Record Key
- eefbb80c-e2aa-4f9e-bd91-cc83fcf6c7e2
Device Description
LANCET GREEN 21G X 1.8MM
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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 |
|---|---|---|---|---|
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | General, Plastic Surgery | 878.4850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61578 | Manual blood lancing device, single-use | A sterile, hand-held manual instrument intended to be used for controlled skin puncture/cut to obtain a capillary blood specimen, performed by a healthcare provider (e.g., on a neonate) or a patient (e.g., a diabetic), typically at the fingertip or ear lobe. It includes a preloaded lancet tip, and has a manually-powered mechanism (e.g., spring-loaded) which enables the tip to puncture to a predetermined depth and blood subsequently to be squeezed out of the puncture site. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16950383616255 | GS1 | Carton | 50 | In Commercial Distribution | |
| Primary | 06950383616258 | GS1 | ||||
| Unit of Use | 86950383616254 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K221839 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 21 | Gauge |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Room Temperature