PA SensiLance Pressure Activated Safety Lancets, Sterile
- Primary DI
- 00616784711225
- Brand
- PA SensiLance Pressure Activated Safety Lancets, Sterile
- Company
- Dynarex Corporation
- Model
- 7112
- Device description
- 21G Needle , 2.2mm Depth, Orange
- Published
- 2021-05-21
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- true
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | General, Plastic Surgery | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00616784711232 | Package | GS1 | 10 | In Commercial Distribution |
| 00616784711225 | Primary | GS1 | 0 | |
| 00810180846806 | Unit of Use | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00616784711232 | 00616784711232 | 616784711232 | 0616784711232 |
| 00616784711225 | 00616784711225 | 616784711225 | 0616784711225 |
| 00810180846806 | 00810180846806 | 810180846806 | 0810180846806 |
GMDN Terms
| Term | Definition |
|---|
| 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. |
Regulatory Flags
- DUNS number
- 008124539
- Device count
- 100
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
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