FDA UDI
In Commercial Distribution
🇺🇸 United States
Marketlab
DI: 00817517026221
·
Model: 108155
·
MARKETLAB INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Marketlab
- Primary DI
- 00817517026221
- Version / Model
- 108155
- Company Name
- MARKETLAB INC.
- Labeler DUNS
- 848917027
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-03
- Public Version
- 1
- Public Version Date
- 2022-08-11
- Public Version Status
- New
- Public Device Record Key
- 4973b248-24e6-499c-a7ed-f900e924c532
Device Description
Disposable Transfer Pipette, 5.0 mL
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
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Clinical Chemistry | 862.2050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45410 | User-induced micropipette | A long, thin tube made of glass or plastic typically used in the laboratory for the manual withdrawal, transfer, and injection of minute volumes of fluid materials (e.g., microlitres or smaller). The user will typically attach a mouthpiece and create a partial vacuum within the device by gently sucking the air from inside the tube, inducing the substance to enter the device, or achieve the same action with a sqeezable bulb/syringe. Closing the mouthpiece or the user end of the pipette will hold the substance therein; dispensing is done by controlled venting of air into the user end or squeezing the bulb/syringe. Device use may include in vitro fertilization (IVF) procedures. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817517026221 | GS1 |