FDA UDI
In Commercial Distribution
🇺🇸 United States
XP-4D
DI: 08404535012200
·
Model: 5031704U0
·
Peter Brasseler Holdings, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- XP-4D
- Primary DI
- 08404535012200
- Version / Model
- 5031704U0
- Catalog Number
- 5031704U0
- Company Name
- Peter Brasseler Holdings, LLC
- Labeler DUNS
- 082080136
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-31
- Public Version
- 3
- Public Version Date
- 2025-03-12
- Public Version Status
- Update
- Public Device Record Key
- 9041f083-7b7b-44f8-b6ce-6e90d667035c
Device Description
XP-4D BIO GP CONES ASST 60P XP
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| EKM | Gutta-Percha | Dental | 872.3850 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45081 | Synthetic gutta-percha | A dental material made from a polymer-based, synthetic gutta-percha containing fillers and radiopacifiers in a soft resin matrix, intended to fill the root canal of a tooth. This material has the ability to resist leakage significantly better than natural gutta-percha based obturation whilst strengthening the root resulting in roots having a coronal and apical seal as part of the canal filling process. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08404535012200 | GS1 |