FDA UDI
In Commercial Distribution
🇺🇸 United States
Pip
DI: 10732671109023
·
Model: 902
·
AMITY HOLDINGS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
6
Pkg Device Count
1
Basic Information
- Brand Name
- Pip
- Primary DI
- 10732671109023
- Version / Model
- 902
- Catalog Number
- 902
- Company Name
- AMITY HOLDINGS, LLC
- Labeler DUNS
- 016069284
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-27
- Public Version
- 2
- Public Version Date
- 2020-10-15
- Public Version Status
- Update
- Public Device Record Key
- ce7f0231-862d-454e-8ed3-208c3c27b2ff
- Distribution End Date
- 2025-08-27
Device Description
Safety Lancet
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 | Lancet, Blood | 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 | 00732671009029 | GS1 | Chipboard Carton | 100 | In Commercial Distribution | 2025-08-27 |
| Primary | 10732671109023 | GS1 | ||||
| Package | 20732671209027 | GS1 | Corrugate Carton | 10 | In Commercial Distribution | 2025-08-27 |
| Package | 30732671309021 | GS1 | Corrugate Carton | 4 | In Commercial Distribution | 2025-08-27 |
| Package | 40732671409025 | GS1 | Chipboard Carton | 10 | In Commercial Distribution | 2025-08-27 |
| Package | 50732671509029 | GS1 | Chipboard Carton | 30 | In Commercial Distribution | 2025-08-27 |
Customer Contacts
- Phone
- 8003278894
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 30 | Gauge | |
| Length | 1.6 | Millimeter |