FDA UDI
In Commercial Distribution
🇺🇸 United States
Tulip GEMS™ Single-Use
DI: 00819127023928
·
Model: DMICRO-01
·
Tulip Medical Products
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Tulip GEMS™ Single-Use
- Primary DI
- 00819127023928
- Version / Model
- DMICRO-01
- Company Name
- Tulip Medical Products
- Labeler DUNS
- 113564152
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-05
- Public Version
- 2
- Public Version Date
- 2025-07-21
- Public Version Status
- Update
- Public Device Record Key
- 5c08c3f8-c5de-447f-af8a-e5187a6da92b
Device Description
Single-Use MicroFat Set for 1 Patients
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QPB | System, Suction, Lipoplasty For Removal | General, Plastic Surgery | 878.5040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63046 | Autologous adipose tissue reinjection set | A collection of devices which includes an invasive cannula/needle, intended for both harvesting fat tissue from a patient (liposuction) and subsequently injecting the fat tissue into the patient from whom it was taken (autologous lipotransfer) as part of a surgical procedure (e.g., reconstructive/cosmetic, orthopaedic, spinal); it may additionally be intended to process the adipose tissue. In addition to needles/cannulae, it includes syringes, accessories (e.g., caps, connectors), and may include collection/processing devices (e.g., filtration bag). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00819127023928 | GS1 |