FDA UDI
In Commercial Distribution
🇺🇸 United States
EZ Trax
DI: 00850041479156
·
Model: 118 INSERT.AL.21.12.2
·
K1 MEDICAL TECHNOLOGIES, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- EZ Trax
- Primary DI
- 00850041479156
- Version / Model
- 118 INSERT.AL.21.12.2
- Catalog Number
- 118 INSERT.AL.21.12.2
- Company Name
- K1 MEDICAL TECHNOLOGIES, LLC
- Labeler DUNS
- 080448429
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-26
- Public Version
- 1
- Public Version Date
- 2024-08-05
- Public Version Status
- New
- Public Device Record Key
- 1e6b37cd-78a9-4205-b0bf-752694a9cf42
Device Description
Insert Aluminum (L)21 (W)12 (H)2
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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | General Hospital | 880.6850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12143 | Instrument tray, reusable | A container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850041479156 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K192487 | 000 |