FDA UDI
In Commercial Distribution
🇺🇸 United States
Henry Schein
DI: 10304040193270
·
Model: 5705590
·
HENRY SCHEIN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
4
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Basic Information
- Brand Name
- Henry Schein
- Primary DI
- 10304040193270
- Version / Model
- 5705590
- Catalog Number
- 5705590
- Company Name
- HENRY SCHEIN, INC.
- Labeler DUNS
- 012430880
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2025-11-26
- Public Version
- 1
- Public Version Date
- 2025-12-04
- Public Version Status
- New
- Public Device Record Key
- 44b97e76-af62-4c55-99be-dd4072c1cb4d
Device Description
Disposable Biopsy Punch 1.5mm 25 per box
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
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| LRY | PUNCH, SURGICAL | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63028 | Skin biopsy blade | A sterile hand-held device intended to be used to surgically remove a tissue specimen from a patient’s skin for histopathological examination (biopsy); it may also be used to remove skin lesions (e.g., skin moles). Sometimes referred to as a biopsy razor blade, it is in the form of a cutting blade, within a plastic case with side grips, which is flexible to help facilitate bending for precise tissue excision. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00304040193273 | GS1 | ||||
| Primary | 10304040193270 | GS1 |