FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Wallace
DI: 15019315082276
·
Model: WIC-55V-45
·
SMITHS MEDICAL ASD, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Wallace
- Primary DI
- 15019315082276
- Version / Model
- WIC-55V-45
- Company Name
- SMITHS MEDICAL ASD, INC.
- Labeler DUNS
- 137835299
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-11
- Public Version
- 3
- Public Version Date
- 2019-10-16
- Public Version Status
- Update
- Public Device Record Key
- 2baa7cee-6a86-4776-b3a3-69b6f09ff4c0
- Distribution End Date
- 2019-09-27
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| MQH | MICROTOOLS, ASSISTED REPRODUCTION (PIPETTES) | Obstetrics/Gynecology | 884.6130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38522 | Mechanical pipette | A manually-operated device typically used in the laboratory to withdraw, transfer, and inject discrete volumes of fluid materials. The device is typically hand-held and operates through an internal mechanism powered by the fingers; it can have a single channel or multichannel piston/cylinder pick-up assembly. The device transfers consistent volumes of liquid into one or several receptacles simultaneously (e.g., the wells of a microtitre plate). A pipette may be factory pre-set to deliver a given volume, or may have user-selectable volumes within a useful volume range. The delivered volume may be mechanically indicated. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 35019315082270 | GS1 | Box | 10 | Not in Commercial Distribution | 2019-09-27 |
| Primary | 15019315082276 | GS1 |