FDA UDI
Not in Commercial Distribution
🇺🇸 United States
PIP
DI: 00732671002334
·
Model: 202TK
·
AMITY HOLDINGS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- PIP
- Primary DI
- 00732671002334
- Version / Model
- 202TK
- Catalog Number
- 202TK
- Company Name
- AMITY HOLDINGS, LLC
- Labeler DUNS
- 016069284
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-29
- Public Version
- 2
- Public Version Date
- 2026-03-05
- Public Version Status
- Update
- Public Device Record Key
- 321b8381-44db-433f-b1b0-1cc1786eb0a2
- Distribution End Date
- 2024-12-31
Device Description
28G Lancet
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
- 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 |
|---|---|---|---|---|
| 37243 | Manual blood lancing device, reusable | A hand-held manual instrument intended to be used for controlled skin puncture to obtain a capillary blood specimen (e.g., performed by a diabetic patient) typically at the fingertip or ear lobe. It is used with a sterile, disposable 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 reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10732671102338 | GS1 | Box | 200 | Not in Commercial Distribution | 2023-12-31 |
| Primary | 00732671002334 | GS1 | ||||
| Package | 20732671202332 | GS1 | Inner Case | 24 | Not in Commercial Distribution | 2023-12-31 |
| Package | 30732671302336 | GS1 | Master Case | 6 | Not in Commercial Distribution | 2023-12-31 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K230712 | 000 |