| Primary Device ID | EBRE540002159 |
| NIH Device Record Key | d76144b3-246e-4cb0-83d5-f885b8fe58d2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pi-Ku-Plast HP 36 polymer |
| Version Model Number | 54000215 |
| Catalog Number | 54000215 |
| Company DUNS | 341086190 |
| Company Name | bredent GmbH & Co. KG |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +4907309872531 |
| regulatory-affairs@bredent.com | |
| Phone | +4907309872531 |
| regulatory-affairs@bredent.com | |
| Phone | +4907309872531 |
| regulatory-affairs@bredent.com | |
| Phone | +4907309872531 |
| regulatory-affairs@bredent.com | |
| Phone | +4907309872531 |
| regulatory-affairs@bredent.com | |
| Phone | +4907309872531 |
| regulatory-affairs@bredent.com | |
| Phone | +4907309872531 |
| regulatory-affairs@bredent.com | |
| Phone | +4907309872531 |
| regulatory-affairs@bredent.com | |
| Phone | +4907309872531 |
| regulatory-affairs@bredent.com | |
| Phone | +4907309872531 |
| regulatory-affairs@bredent.com | |
| Phone | +4907309872531 |
| regulatory-affairs@bredent.com | |
| Phone | +4907309872531 |
| regulatory-affairs@bredent.com | |
| Phone | +4907309872531 |
| regulatory-affairs@bredent.com | |
| Phone | +4907309872531 |
| regulatory-affairs@bredent.com | |
| Phone | +4907309872531 |
| regulatory-affairs@bredent.com | |
| Phone | +4907309872531 |
| regulatory-affairs@bredent.com | |
| Phone | +4907309872531 |
| regulatory-affairs@bredent.com | |
| Phone | +4907309872531 |
| regulatory-affairs@bredent.com |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EBRE540002150 [Primary] |
| HIBCC | EBRE540002159 [Package] Contains: EBRE540002150 Package: dummy [1 Units] Discontinued: 2023-11-23 Not in Commercial Distribution |
| EGD | WAX, DENTAL, INTRAORAL |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-12-01 |
| Device Publish Date | 2023-11-23 |
| EBREVLCOLBLACK9 - visio.lign color Black | 2025-03-18 visio.lign color Black 2.6 ml |
| EBREVLCOLBLUE9 - visio.lign color Blue | 2025-03-18 visio.lign color Blue 2.6 ml |
| EBREVLCOLBODYA9 - visio.lign color Body A | 2025-03-18 visio.lign color Body A 2.6 ml |
| EBREVLCOLBODYB9 - visio.lign color Body B | 2025-03-18 visio.lign color Body B 2.6 ml |
| EBREVLCOLBODYC9 - visio.lign color Body C | 2025-03-18 visio.lign color Body C 2.6 ml |
| EBREVLCOLBODYD9 - visio.lign color Body D | 2025-03-18 visio.lign color Body D 2.6 ml |
| EBREVLCOLBROWN9 - visio.lign color Brown | 2025-03-18 visio.lign color Brown 2.6 ml |
| EBREVLCOLCREME9 - visio.lign color Creme | 2025-03-18 visio.lign color Creme 2.6 ml |