FDA UDI
In Commercial Distribution
🇺🇸 United States
Applicator brush (endo<black>)
DI: EKUR001025KA1
·
Model: #1025-KA
·
KURARAY NORITAKE DENTAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
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Basic Information
- Brand Name
- Applicator brush (endo<black>)
- Primary DI
- EKUR001025KA1
- Version / Model
- #1025-KA
- Company Name
- KURARAY NORITAKE DENTAL INC.
- Labeler DUNS
- 697119498
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2024-08-26
- Public Version
- 1
- Public Version Date
- 2024-09-03
- Public Version Status
- New
- Public Device Record Key
- 0228e88b-8c00-45b1-8cbd-d7d87d7d3c5f
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
|---|---|---|---|---|
| KXR | Applicator, Resin | Dental | 872.3140 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35967 | Surgical retraction system mounting frame, reusable | A noninvasive mounting device (e.g., a large ring, table-fixed bridging bar) designed as a component of a surgical retraction system, intended to be placed/fixed around a surgical incision site and upon which retraction system blades/components are mounted to temporarily part tissue (e.g., hold the edges of an incision open) to expose internal tissues or organs for access during surgery. It does not include the invasive retraction blades/components (i.e., is not the complete system). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | EKUR001025KA0 | HIBCC | ||||
| Primary | EKUR001025KA1 | HIBCC |