FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 00724995208127
·
Model: Argon Gas-G1120010
·
US Endoscopy
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 00724995208127
- Version / Model
- Argon Gas-G1120010
- Catalog Number
- G11200101
- Company Name
- US Endoscopy
- Labeler DUNS
- 627879687
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-02-18
- Public Version
- 2
- Public Version Date
- 2023-04-04
- Public Version Status
- Update
- Public Device Record Key
- 9473f2e1-ac1b-4dfe-aaaf-e4a413bac114
Device Description
The Argon gas canister is used with gi4000 electrosurgical unit.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEI | Electrosurgical, cutting & coagulation & accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65342 | Electrosurgery gas/non-refillable cylinder | Compressed inert gas [e.g., argon (Ar), helium (He)] in a dedicated, cylindrical container intended to be used as the gas source for inert gas-enhanced electrosurgery. The container typically includes a tube with an opening/closing valve, and may be graded according to size (capacity) and colour-coded/labelled to denote gas content and intended use. This device is reusable until the contents of the container are exhausted. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10724995208124 | GS1 | Box | 2 | In Commercial Distribution | |
| Primary | 00724995208127 | GS1 |
Customer Contacts
- Phone
- +1(800)548-4873
- [email protected]
Premarket Submissions
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- High: 125 Degrees Fahrenheit