FDA UDI
In Commercial Distribution
🇺🇸 United States
Enbio-Autoclave Control Firmware
DI: 07629999282957
·
Model: 36
·
Enbio Group AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Enbio-Autoclave Control Firmware
- Primary DI
- 07629999282957
- Version / Model
- 36
- Company Name
- Enbio Group AG
- Labeler DUNS
- 480232605
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-02
- Public Version
- 1
- Public Version Date
- 2026-03-10
- Public Version Status
- New
- Public Device Record Key
- 07d11de2-db75-46b0-aecf-5645e063f854
Device Description
Firmware dedicated only to the Enbio S/PRO autoclave and created by our company. This firmware does not give the possibility to the end user of any interference in the device operating parameters and records of carried out sterilization or tests.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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 |
|---|---|---|---|---|
| FLE | Sterilizer, Steam | General Hospital | 880.6880 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38671 | Steam sterilizer | A mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from medical devices and related products using pressurized steam (i.e., moist heat) as the sterilizing agent; it is used for products non-sensitive to high temperature, water, or steam. It typically includes a treatment chamber with shelves for device placement, and controls; it may be intended to sterilize wrapped and/or unwrapped devices. The device is available in a variety of shapes and sizes, including stand-alone (bulk) and tabletop units. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07629999282957 | GS1 |
Customer Contacts
- Phone
- +18786701641
- [email protected]