FDA UDI
In Commercial Distribution
🇺🇸 United States
Henry Schein
DI: 10304040029029
·
Model: 9007982
·
HENRY SCHEIN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- Henry Schein
- Primary DI
- 10304040029029
- Version / Model
- 9007982
- Catalog Number
- 9007982
- Company Name
- HENRY SCHEIN, INC.
- Labeler DUNS
- 012430880
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2018-09-24
- Public Version
- 1
- Public Version Date
- 2018-10-25
- Public Version Status
- New
- Public Device Record Key
- 1aa53ba6-1c7e-47e4-afe7-9ae293f46b82
Device Description
Lancet Safety Press Act Rose
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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
- Yes
- 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
- Yes
- Sterilization Methods
- Radiation Sterilization
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 | 20304040029026 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 10304040029029 | GS1 | ||||
| Unit of Use | 00304040029022 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Needle Gauge:0.81mm | ||
| Depth | 2.8 | Millimeter |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 30 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- devices kept at room temperature
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 40 Degrees Celsius