FDA UDI
In Commercial Distribution
🇺🇸 United States
Tulip GEMS™ Single-Use
DI: 00819127022594
·
Model: ABS10055
·
Tulip Medical Products
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Tulip GEMS™ Single-Use
- Primary DI
- 00819127022594
- Version / Model
- ABS10055
- Company Name
- Tulip Medical Products
- Labeler DUNS
- 113564152
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-12
- Public Version
- 1
- Public Version Date
- 2019-07-22
- Public Version Status
- New
- Public Device Record Key
- ffeb858f-86cd-4839-971d-ea9e6410df83
Device Description
Premium Single-Use Procedure Kit for Adipose Tissue Harvesting
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36107 | Liposuction system cannula, single-use | A rigid tube that functions as a component of a lipectomy suction system and designed specifically for percutaneous insertion into body fat deposits for the aspiration of fat during liposuction/lipoplasty. The device may also be used to infiltrate the operative site with a solution during the procedure, which is then aspirated. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00819127022594 | GS1 |