| Primary Device ID | J021303580000 |
| NIH Device Record Key | 005a821c-4265-47e7-bb8d-d4ac68588566 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Perestaltic Pump |
| Version Model Number | 30358000 |
| Company DUNS | 300238441 |
| Company Name | W & H Dentalwerk Bürmoos GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | J021303580000 [Direct Marking] |
| HIBCC | J021303580001 [Primary] |
| EIA | Unit, Operative Dental |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-27 |
| Device Publish Date | 2023-07-19 |
| J021302100000 - SI-SQ | 2024-09-19 Osstell Module |
| J021100355000 - ZA-55 L Scaler | 2024-08-08 Air Scaler with light |
| J021100355010 - ZA-55 Scaler | 2024-08-08 ZA-55 Scaler without light |
| J021100355020 - ZA-55 LM Air Scaler | 2024-08-08 Air Scaler with light |
| J021100355030 - ZA-55 M Scaler without light | 2024-08-08 Air Scaler without light |
| J021100355110 - SF1LM KO Air Scaler | 2024-08-08 Brasseler Air Scaler |
| J021100355120 - SF1LM A1 Air Scaler | 2024-08-08 Air Scaler Brasseler |
| J021100355311 - ZA-55 Synea Scaler | 2024-08-08 |