FDA UDI
In Commercial Distribution
🇺🇸 United States
Henry Schein
DI: 10304040052287
·
Model: 1126195
·
HENRY SCHEIN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
100
Basic Information
- Brand Name
- Henry Schein
- Primary DI
- 10304040052287
- Version / Model
- 1126195
- Catalog Number
- 1126195
- 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
- ff84b8ec-cabe-470b-b013-2505834ce3dd
Device Description
Surgeon Blades SS Sterile
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
- 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 |
|---|---|---|---|---|
| GES | BLADE, SCALPEL | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37065 | Ultrasonic orthopaedic cement extractor | A hand-operated, electrically-powered surgical instrument that uses ultrasonic energy for the extraction of orthopaedic (bone) cement from a site of previous application, typically during the procedure to replace a previously cemented prosthesis. This GMDN code may include an aspirating device for the removal of cement/bone fragments. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20304040052284 | GS1 | case | 10 | In Commercial Distribution | |
| Primary | 10304040052287 | GS1 | ||||
| Package | 30304040052281 | GS1 | Carton | 40 | In Commercial Distribution | |
| Unit of Use | 00304040052280 | GS1 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 45 Degrees Celsius