| Primary Device ID | 00867009000215 |
| NIH Device Record Key | a928615e-55c4-4146-9cab-e1fc95a18d80 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FMAT1 Prism B |
| Version Model Number | Prism B |
| Company DUNS | 010283033 |
| Company Name | FALCK MEDICAL INC |
| 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 | true |
| Lot Batch | true |
| 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 | true |
| OTC Over-The-Counter | false |
| Length | 35 Centimeter |
| Handling Environment Temperature | Between 20 Degrees Celsius and 35 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00867009000215 [Primary] |
| GS1 | 10867009000212 [Package] Package: Inner Pack [250 Units] In Commercial Distribution |
| GS1 | 20867009000219 [Package] Contains: 10867009000212 Package: Case [5 Units] In Commercial Distribution |
| HKY | Tonometer, Manual |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00867009000215]
Liquid Chemical
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-07-08 |
| 00867009000208 - Falck Medical Multi-Function Applanation Tonometer | 2018-03-29 Indications for Use: Intraocular Pressure, Ocular Pulse Amplitude, Ophthalmodynamometry and Tonography Measurement |
| 00867009000215 - FMAT1 Prism B | 2018-03-29Disposable single use prism for FMAT1 Device |
| 00867009000215 - FMAT1 Prism B | 2018-03-29 Disposable single use prism for FMAT1 Device |