FDA UDI
Not in Commercial Distribution
🇺🇸 United States
LifeGlobal® Micropipet
DI: 00815965022017
·
Model: MPIC-L775-20*01*
·
LIFEGLOBAL GROUP, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- LifeGlobal® Micropipet
- Primary DI
- 00815965022017
- Version / Model
- MPIC-L775-20*01*
- Catalog Number
- MPIC-L775-20*01*
- Company Name
- LIFEGLOBAL GROUP, LLC
- Labeler DUNS
- 141732011
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 4
- Public Version Date
- 2020-07-03
- Public Version Status
- Update
- Public Device Record Key
- 5d337394-e6f4-4c44-aab2-e17c48971506
- Distribution End Date
- 2018-10-31
Device Description
LG µPipets®: Injection w spike TEL775µm, 20° - BLUE (1pc)
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
- No
- 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
- 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 |
|---|---|---|---|---|
| MQJ | MICROMANIPULATORS AND MICROINJECTORS, ASSISTED REPRODUCTION | Obstetrics/Gynecology | 884.6150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46553 | Assisted reproduction microtool | A dedicated pipette or other device used in the laboratory to denude, micromanipulate, hold, or transfer human gametes or embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00815965022208 | GS1 | box,MPIC-L775-20 | 10 | Not in Commercial Distribution | 2018-10-31 |
| Primary | 00815965022017 | GS1 |
Customer Contacts
- Phone
- +1(800)720-6375
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Tip-to-Elbow length 0.750-0.800mm | ||
| Device Size Text, specify | angle of tip | ||
| Angle | 20 | degree | |
| Device Size Text, specify | spiked tip | ||
| Device Size Text, specify | Inner Diameter 4.0-5.0µm |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not use if package is damaged
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry