FDA UDI
In Commercial Distribution
🇺🇸 United States
INUMI Flex Needle
DI: 00850031859081
·
Model: GTI-00054
·
Galvanize Therapeutics, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- INUMI Flex Needle
- Primary DI
- 00850031859081
- Version / Model
- GTI-00054
- Company Name
- Galvanize Therapeutics, Inc.
- Labeler DUNS
- 070000990
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2025-02-28
- Public Version
- 1
- Public Version Date
- 2025-03-10
- Public Version Status
- New
- Public Device Record Key
- 46ea18ed-4bfc-430b-9341-1247f1ac82cd
Device Description
INUMI Flex Needle, 5 pack
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
| OAB | Low Energy Direct Current Thermal Ablation System | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 67470 | Irreversible electroporation system endoscopic probe | A hollow, long, tubular electrical conductor with a sharply-pointed distal end intended for endoscopic introduction to deliver short electrical pulses, in a monopolar configuration, to produce irreversible cell membrane electroporation for ablation of soft tissue (excludes cardiac tissue). It is intended to be proximally connected to a connection electrode with a connection cable for use in conjunction with an appropriate generator. It may include a stylet intended to facilitate introduction; the connection electrode and connection cable are not included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00850031859074 | GS1 | ||||
| Primary | 00850031859081 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K233884 | 000 |