FDA UDI
In Commercial Distribution
🇺🇸 United States
LifeGlobal® GPS® Dishware
DI: 00815965021782
·
Model: UGPS-010
·
LIFEGLOBAL GROUP, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- LifeGlobal® GPS® Dishware
- Primary DI
- 00815965021782
- Version / Model
- UGPS-010
- Catalog Number
- UGPS-010
- Company Name
- LIFEGLOBAL GROUP, LLC
- Labeler DUNS
- 141732011
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 5
- Public Version Date
- 2023-02-20
- Public Version Status
- Update
- Public Device Record Key
- 95880b05-0d47-4a0c-bc39-6f38439f38bb
Device Description
Universal GPS Dish - (1 sleeve of 10)
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 |
|---|---|---|---|---|
| MQK | LABWARE, ASSISTED REPRODUCTION | Obstetrics/Gynecology | 884.6160 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56648 | Assisted reproduction procedure dish | A container intended exclusively for preparing and culturing gametes or embryos for use in assisted reproduction techniques (ART). Such techniques include in vitro fertilization (IVF), fertilization via intracytoplasmic sperm injection (ICSI), or other in IVF procedures used in assisted reproduction clinics. It is available in a variety of shapes and sizes (e.g., multi-well dishes, Petri dishes, ICSI dishes) and is typically designed with an optically clear bottom for optimum manipulation and observation of ova and embryos. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00815965021782 | GS1 | ||||
| Unit of Use | 00815965021607 | GS1 |
Customer Contacts
- Phone
- +1(800)720-6375
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K080395 | 000 |
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