Brasseler USA
- Primary DI
- 00887919628705
- Brand
- Brasseler USA
- Company
- Peter Brasseler Holdings, LLC
- Model
- 5017964U0
- Device description
- SEQ GUTTA PERCHA 30 06 60P
- Published
- 2022-12-01
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Related Records
Product Codes
| Code | Name |
|---|---|
| EKM | GUTTA-PERCHA |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| EKM | Gutta-Percha | Dental | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00887919628705 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00887919628705 | 00887919628705 | 887919628705 | 0887919628705 |
GMDN Terms
| Term | Definition |
|---|---|
| Natural gutta-percha | A dental material made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. This material is softened by heat and inserted into the root canal, where it hardens as it cools. After application, this device cannot be reused. |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 082080136
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
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|---|---|---|---|---|
| 08404535019247 | Brasseler USA | 5031780U0 | 5031780U0 | 2026-03-24 |
| 08404535024906 | Brasseler USA | 5032029U0 | 5032029U0 | 2026-03-23 |
| 08404535024937 | Brasseler USA | 5032030U0 | 5032030U0 | 2026-03-23 |
| 08404535024968 | Brasseler USA | 5032031U0 | 5032031U0 | 2026-03-23 |
| 08404535025156 | LARGE BONE BLADES | BR1-12100-50 | BR1-12100-50 | 2026-03-23 |
| 08404535024579 | Brasseler USA | FL17CHP | 5032016U0 | 2026-03-17 |
| 08404535024609 | Brasseler USA | FL17MHP | 5032017U0 | 2026-03-17 |
| 08404535024630 | Brasseler USA | FL17FHP | 5032018U0 | 2026-03-17 |
| 08404535024661 | Brasseler USA | FL17UF | 5032019U0 | 2026-03-17 |
| 08404535021769 | BrioPrep Sterile Diamonds | 5031856U0 | 5031856U0 | 2025-11-21 |
| 08404535021790 | BrioPrep Sterile Diamonds | 5031857U0 | 5031857U0 | 2025-11-21 |
| 08404535021820 | BrioPrep Sterile Diamonds | 5031858U0 | 5031858U0 | 2025-11-21 |
| 08404535021851 | BrioPrep Sterile Diamonds | 5031859U0 | 5031859U0 | 2025-11-21 |
| 08404535021882 | BrioPrep Sterile Diamonds | 5031860U0 | 5031860U0 | 2025-11-21 |
| 08404535021912 | BrioPrep Sterile Diamonds | 5031861U0 | 5031861U0 | 2025-11-21 |
| 08404535021943 | BrioPrep Sterile Diamonds | 5031862U0 | 5031862U0 | 2025-11-21 |
| 08404535021974 | BrioPrep Sterile Diamonds | 5031863U0 | 5031863U0 | 2025-11-21 |
| 08404535022001 | BrioPrep Sterile Diamonds | 5031864U0 | 5031864U0 | 2025-11-21 |
| 08404535022124 | BrioPrep Sterile Diamonds | 5031880U0 | 5031880U0 | 2025-11-21 |
| 08404535022155 | BrioPrep Sterile Diamonds | 5031881U0 | 5031881U0 | 2025-11-21 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 06978880221102 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221119 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221126 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221133 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221140 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221157 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221164 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221171 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221188 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221195 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221201 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221218 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221225 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221232 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221249 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221256 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221263 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221270 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221287 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221294 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221300 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221317 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221324 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221331 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221348 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221355 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221362 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221379 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221386 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221393 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |