FDA UDI
In Commercial Distribution
🇺🇸 United States
Minerva Argon Gas Canister (5 pack)
DI: 00862393000131
·
Model: MINARGC
·
Minerva Surgical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- Minerva Argon Gas Canister (5 pack)
- Primary DI
- 00862393000131
- Version / Model
- MINARGC
- Catalog Number
- MINARGC
- Company Name
- Minerva Surgical, Inc.
- Labeler DUNS
- 829616478
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2017-06-27
- Public Version
- 10
- Public Version Date
- 2023-04-04
- Public Version Status
- Update
- Public Device Record Key
- 4d3191e7-419c-47a7-8fd6-db0d570f6952
Device Description
Minerva Argon Gas Canister (offered in 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
- No
- 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 |
|---|---|---|---|---|
| MNB | Device, Thermal Ablation, Endometrial | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62227 | Inert gas-enhanced endoscopic electrosurgical submucosal lift/resection instrument | A flexible, invasive, endoscopic device intended to deliver both: 1) a submucosal lifting solution; and 2) electrosurgical current within a stream of inert gas [e.g., argon (Ar), helium (He)] (in a monopolar configuration) to tissues for cutting/coagulation. It is typically intended to treat gastrointestinal mucosal lesions through lifting of diseased mucosa over a bubble of fluid, and subsequent ablation of the diseased area by gas plasma coagulation. It is a long, thin electrode/luminal needle intended to be connected to a parent device (i.e., inert gas-enhanced electrosurgical system generator/gas delivery unit, and fluid pump); it does not include controls. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00862393000131 | GS1 | ||||
| Unit of Use | 10862393000138 | GS1 |
Customer Contacts
- Phone
- 855-646-7874
- [email protected]