FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 00862992000341
·
Model: FRONT-LINE FL120
·
FORT DEFIANCE INDUSTRIES, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 00862992000341
- Version / Model
- FRONT-LINE FL120
- Company Name
- FORT DEFIANCE INDUSTRIES, LLC
- Labeler DUNS
- 178610390
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-02
- Public Version
- 1
- Public Version Date
- 2023-08-10
- Public Version Status
- New
- Public Device Record Key
- 2b0721c2-01f9-4c2f-b319-bc2b4cf4fbfd
Device Description
The Fort Defiance Industries FRONT-LINE Field Sterilizers are autoclaves designed for sterilizing heat- and moisture-stable medical, dental, and surgical materials, including wrapped and unwrapped, solid, porous, and hollow items (e.g., dental handpieces, suction pipes) in healthcare facilities.
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| 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 | 00862992000341 | GS1 |
Customer Contacts
- Phone
- 865-408-0100
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K213457 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 31.3125 | Inch | |
| Width | 19.875 | Inch | |
| Height | 21.625 | Inch | |
| Weight | 139 | Pound |