FDA UDI
In Commercial Distribution
🇺🇸 United States
Olympus
DI: 04042761083591
·
Model: WA94043A
·
OLYMPUS Winter & Ibe GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Olympus
- Primary DI
- 04042761083591
- Version / Model
- WA94043A
- Catalog Number
- WA94043A
- Company Name
- OLYMPUS Winter & Ibe GmbH
- Labeler DUNS
- 316957240
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-31
- Public Version
- 2
- Public Version Date
- 2021-09-20
- Public Version Status
- Update
- Public Device Record Key
- d65f6157-be7d-4c47-83a8-779d69735893
Device Description
Pressure reducer with connector acc. to CGA No. 580, for Argon Plasma Coagulation
Device Characteristics
- Single Use
- No
- 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
- 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
- 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 |
|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36154 | Argon-enhanced electrosurgical system gas delivery unit | A device designed to deliver argon (Ar) gas from an Ar gas source to an argon-enhanced electrosurgical system. It is typically incorporated into a trolley (cart) and is connected to the electrosurgical diathermy generator, enabling a single control for the system. The argon gas is delivered through an appropriate handpiece and active electrode (not included) to minimize tissue charring and enhance coagulation at and around the site of operation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04042761083591 | GS1 |
Customer Contacts
- Phone
- +1(800)401-1086
- [email protected]