| Primary Device ID | 08720387388110 |
| NIH Device Record Key | 09b51036-2638-40b7-9faf-332ea83f4e84 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AFCS PEARLS™ & SANDS™ Corner clamps |
| Version Model Number | SAT1 / SAT2 |
| Catalog Number | 2010311 |
| Company DUNS | 417294923 |
| Company Name | Synergie Nederland B.V. |
| 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 | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08720387388110 [Primary] |
| INX | Bed, Air Fluidized |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-08-30 |
| Device Publish Date | 2021-08-20 |
| 08720387388004 - AFCS PEARLS™ Control unit | 2021-08-30 Air-Fluidized bed - see www.synergiecare.com AFCS PEARLS™ (SAT2) Innovative care Control Unit |
| 08720387388011 - AFCS PEARLS™ Bed unit | 2021-08-30 Air-Fluidized bed - see www.synergiecare.com AFCS PEARLS™ (SAT2) Innovative care Bed/Frame |
| 08720387388028 - AFCS PEARLS™ Extension Hose | 2021-08-30 Air-Fluidized bed - see www.synergiecare.com Extension hose to place the control unit seperate from the bed unit |
| 08720387388035 - AFCS PEARLS™ Air filter | 2021-08-30 Air-Fluidized bed - see www.synergiecare.com AFCS PEARLS™ (SAT2) Air filter |
| 08720387388042 - AFCS PEARLS™ Filter sheet large multifilament | 2021-08-30 Air-Fluidized bed - see www.synergiecare.com AFCS PEARLS™ (SAT2) Filter sheet large multifilament |
| 08720387388059 - AFCS PEARLS™ Filter sheet small multifilament | 2021-08-30 Air-Fluidized bed - see www.synergiecare.com AFCS PEARLS™ (SAT2) Filter sheet small multifilament |
| 08720387388066 - AFCS PEARLS™ Filter sheet large monofilament | 2021-08-30 Air-Fluidized bed - see www.synergiecare.com AFCS PEARLS™ (SAT2) Filter sheet large monofilament |
| 08720387388073 - AFCS PEARLS™ Filter sheet small monofilament | 2021-08-30 Air-Fluidized bed - see www.synergiecare.com AFCS PEARLS™ (SAT2) Filter sheet small monofilament |