FDA UDI
In Commercial Distribution
🇺🇸 United States
Zeramex XT Surgery Tray, fully equipped
DI: 07640161392809
·
Model: XT48854
·
CeramTec Schweiz GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Zeramex XT Surgery Tray, fully equipped
- Primary DI
- 07640161392809
- Version / Model
- XT48854
- Catalog Number
- XT48854
- Company Name
- CeramTec Schweiz GmbH
- Labeler DUNS
- 483229493
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-30
- Public Version
- 7
- Public Version Date
- 2024-12-11
- Public Version Status
- Update
- Public Device Record Key
- 7b760fad-d9c6-490d-a403-6767428458f1
Device Description
Tools
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- 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 |
|---|---|---|---|---|
| NDP | Accessories, implant, dental, endosseous | Dental | 872.3980 | 1 |
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 | 07640161392809 | GS1 |
Customer Contacts
- Phone
- +41443883630
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry, Keep out of sunlight
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius