FDA UDI
In Commercial Distribution
🇺🇸 United States
SAFETICET
DI: 08887629000114
·
Model: SC-180
·
NSP TECH PTE LTD
Product Codes
1
GMDN Terms
1
Identifiers
7
Pkg Device Count
1
Basic Information
- Brand Name
- SAFETICET
- Primary DI
- 08887629000114
- Version / Model
- SC-180
- Company Name
- NSP TECH PTE LTD
- Labeler DUNS
- 653632729
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-04-26
- Public Version
- 2
- Public Version Date
- 2022-11-02
- Public Version Status
- Update
- Public Device Record Key
- 8196e7fd-dcee-4dfd-991d-65ed99be2065
- Distribution End Date
- 2025-06-18
Device Description
Lancets are used to make punctures to obtain small blood specimens, are generally disposable, and are commonly used by diabetes patient. the small blood samples can be tested for blood glucose, hemoglobin, and many other blood components. lancets are also used to prick the skin in skin testing for allergies.
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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Radiation Sterilization
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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Package | 08887629000121 | GS1 | box packaging | 10 | In Commercial Distribution | 2025-06-18 |
| Primary | 08887629000114 | GS1 | ||||
| Package | 08887629000138 | GS1 | box packaging | 50 | In Commercial Distribution | 2025-06-18 |
| Package | 08887629000145 | GS1 | box packaging | 100 | In Commercial Distribution | 2025-06-18 |
| Package | 18887629000142 | GS1 | box packaging | 20 | In Commercial Distribution | 2025-06-18 |
| Package | 18887629000135 | GS1 | box packaging | 40 | In Commercial Distribution | 2025-06-18 |
| Package | 18887629000128 | GS1 | box packaging | 200 | In Commercial Distribution | 2025-06-18 |
Customer Contacts
- Phone
- +6567478817
- [email protected]
- Phone
- +16463518664
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 23 | Gauge |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Not exposed to direct sunlight