FDA UDI
In Commercial Distribution
🇺🇸 United States
PureSet™
DI: 07332747167184
·
Model: PUR0400
·
Nobel Biocare AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PureSet™
- Primary DI
- 07332747167184
- Version / Model
- PUR0400
- Catalog Number
- PUR0400
- Company Name
- Nobel Biocare AB
- Labeler DUNS
- 353939929
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-09-19
- Public Version
- 7
- Public Version Date
- 2022-12-12
- Public Version Status
- Update
- Public Device Record Key
- bdc4b48e-573f-4a43-921f-7c3ca4a466f9
Device Description
Nobel Biocare N1™ PureSet Tray
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
- 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 | 07332747167184 | GS1 |
Customer Contacts
- Phone
- +1(800)322-5001
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191475 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 115.000 | Millimeter | |
| Length | 122.100 | Millimeter | |
| Height | 45.600 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight. Keep dry