FDA UDI
In Commercial Distribution
🇺🇸 United States
Xi Adapter
DI: 00816634020389
·
Model: Xi Adapter
·
Ultra Clean Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Xi Adapter
- Primary DI
- 00816634020389
- Version / Model
- Xi Adapter
- Company Name
- Ultra Clean Systems, Inc.
- Labeler DUNS
- 010043227
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-09
- Public Version
- 1
- Public Version Date
- 2025-07-17
- Public Version Status
- New
- Public Device Record Key
- 104fba34-615c-4748-8fcc-050d54609361
Device Description
X/Xi 1101 Adapters - 6/PK X/Xi Triton Adapters - 10/PK
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
- Yes
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| FLG | Cleaner, Ultrasonic, Medical Instrument | General Hospital | 880.6150 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36749 | Ultrasonic-cleaning water bath | An electrically-powered device intended to be used to clean instruments/utensils with ultrasonic waves transmitted from its integral transducers through water contained in a bath. A dedicated cleaning agent may be added to the water to enhance the cleaning effect. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00816634020396 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 00816634020389 | GS1 | ||||
| Package | 00816634020402 | GS1 | Box | 6 | In Commercial Distribution |