Primary Device ID | 06438147013890 |
NIH Device Record Key | fa4dfb4f-1da6-4e6c-8f59-7fd9ee785933 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Wallac DBS Puncher |
Version Model Number | 1296-071 |
Catalog Number | 1296-071 |
Company DUNS | 540156544 |
Company Name | Wallac Oy |
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 | true |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 06438147013890 [Primary] |
LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-05-08 |
Device Publish Date | 2019-04-30 |
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06438147386963 - Iduronate 2-sulfatase S&IS | 2023-04-25 Vials contain Iduronate 2-sulfatase -substrate and Iduronate 2-sulfatase -internal standard, which can be used to measure the Id |
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06438147373901 - Eonis Analysis software | 2022-12-12 The Eonis Analysis Software is intended for in vitro diagnostic use for analysis of the real time PCR data generated usingthe Eo |
06438147377718 - Eonis DNA Extraction kit | 2022-12-08 The Eonis DNA Extraction kit is a device intended for isolation and purification of DNA in newborn blood specimens dried on filt |