FDA UDI
In Commercial Distribution
🇺🇸 United States
Wallac Plate Shake
DI: 06438147064540
·
Model: 1296-004
·
Wallac Oy
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Wallac Plate Shake
- Primary DI
- 06438147064540
- Version / Model
- 1296-004
- Catalog Number
- 1296-004
- Company Name
- Wallac Oy
- Labeler DUNS
- 540156544
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-02-25
- Public Version
- 2
- Public Version Date
- 2021-04-21
- Public Version Status
- Update
- Public Device Record Key
- 79a8364a-41f3-4963-9892-2f19b56c0ab6
Device Description
1296-004 DELFIA® Plateshake is intended to be used with DELFIA reagents but can also be used for other applications where shaking of microtitration plates is required. One to four plates can be on the shaker simultaneously.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JRQ | Shaker/Stirrer | Clinical Chemistry | 862.2050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15178 | Laboratory shaker | An electromechanical device, typically used in the laboratory or a blood bank, designed to shake/stir samples or mixtures with a rapid and forceful movement. It is used to provide a rapid mixing or to prevent substances comprised of different components from separation or sedimentation because of their different densities. It may be designed to secure single and/or multiple specimen containers (e.g., test tube, microplate) or specimen container holders during the shaking cycle; some types may have selectable agitation frequencies. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06438147064540 | GS1 |