FDA UDI
In Commercial Distribution
🇺🇸 United States
Veress Needle
DI: 04714127862002
·
Model: FVN112000
·
UNIMAX MEDICAL SYSTEMS INC.
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Veress Needle
- Primary DI
- 04714127862002
- Version / Model
- FVN112000
- Company Name
- UNIMAX MEDICAL SYSTEMS INC.
- Labeler DUNS
- 658122465
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-09
- Public Version
- 4
- Public Version Date
- 2020-07-14
- Public Version Status
- Update
- Public Device Record Key
- 977f1b5d-247e-4009-a1f0-3ff0e0ea53bd
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
- Yes
- 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
- 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 |
|---|---|---|---|---|
| FHO | Pneumoperitoneum Needle | Gastroenterology, Urology | 876.1500 | 2 |
| HIF | Insufflator, Laparoscopic | Obstetrics/Gynecology | 884.1730 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12750 | Spring-loaded pneumoperitoneum needle, single-use | A slender, sharply-pointed metal tube designed to introduce or remove gas from the peritoneal cavity as a therapeutic or surgical/radiological procedural method. It is often inserted into the peritoneal cavity for the purpose of insufflation [e.g., with carbon dioxide (CO2)] to establish pneumoperitoneum prior to abdominal endoscopy. It is equipped with a spring-loaded, round-tipped obturator that extends from the tube when the device does not encounter resistance (i.e., when the cavity has been reached) to prevent damage from the sharp point. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 24714127862006 | GS1 | Carton | 100 | In Commercial Distribution | |
| Package | 14714127862009 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 04714127862002 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K111441 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 12 | Centimeter |