Primary Device ID | 20858835007817 |
NIH Device Record Key | 6ad0c394-eecc-4e80-9696-1c01ca670e37 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Bio-Guard Safety Needles |
Version Model Number | BIO-1023S |
Catalog Number | BIO-1023S |
Company DUNS | 065762392 |
Company Name | BIOTRONIX HEALTHCARE INDUSTRIES, 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 | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
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Device Issuing Agency | Device ID |
---|---|
GS1 | 00858835007813 [Primary] |
GS1 | 10858835007810 [Package] Contains: 00858835007813 Package: Inner Box [100 Units] In Commercial Distribution |
GS1 | 20858835007817 [Package] Contains: 10858835007810 Package: Case [8 Units] In Commercial Distribution |
FMI | Needle, Hypodermic, Single Lumen |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2019-12-24 |
Device Publish Date | 2019-10-10 |
20858835007824 | Disposable Bio-Gaurd Safety Needles 25G x 5/8" |
20858835007817 | Disposable Bio-Gaurd Safety Needles 22G x 1" |