FDA UDI
In Commercial Distribution
🇺🇸 United States
MIXOR
DI: 03596010381392
·
Model: 71270020
·
Smith & Nephew, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MIXOR
- Primary DI
- 03596010381392
- Version / Model
- 71270020
- Catalog Number
- 71270020
- Company Name
- Smith & Nephew, Inc.
- Labeler DUNS
- 045483575
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-08-29
- Public Version
- 3
- Public Version Date
- 2023-09-07
- Public Version Status
- Update
- Public Device Record Key
- 39f10832-3735-446a-88b9-3e44fbcc9f34
Device Description
MIXOR VACUUM SYSTEM WITH SYRINGE
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- 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 |
|---|---|---|---|---|
| JDZ | MIXER, CEMENT, FOR CLINICAL USE | Orthopedic | 888.4210 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36000 | Orthopaedic cement mixing bowl | A sterile device designed for the specific purpose of containing the components that comprise orthopaedic bone cement while these are being mixed prior to application on a patient. It is typically used together with an orthopaedic cement mixer. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 23596010381396 | GS1 | BX | 10 | In Commercial Distribution | |
| Primary | 03596010381392 | GS1 |
Customer Contacts
- Phone
- +1(800)238-7538
- [email protected]