Primary Device ID | H816MTSI4402 |
NIH Device Record Key | 0b7d92c3-b5ac-45c1-a491-2c0cbd13f312 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ProChek S |
Version Model Number | TSI440 |
Catalog Number | TSI440-1 |
Company DUNS | 118518186 |
Company Name | MicroCare, LLC |
Device Count | 100 |
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 | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | H816MTSI4400 [Unit of Use] |
HIBCC | H816MTSI4401 [Primary] |
HIBCC | H816MTSI4402 [Package] Contains: H816MTSI4401 Package: [6 Units] In Commercial Distribution |
HIBCC | H816TSI4401 [Previous] |
JOJ | Indicator, Physical/Chemical Sterilization Process |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-11-03 |
Device Publish Date | 2022-10-26 |
H816SMQEZ22 - Spec Clean Endoscope Sponge | 2023-09-07 Enzymatic Presaturated Endoscopic Cleaning Sponge |
H816MBB0312H2 - ProBarrier | 2022-11-03 Environmental Surface Barrier, 3 x 12 instrument/equipment drape, chair sox |
H816MBB0528X2 - ProBarrier | 2022-11-03 Environmental Surface Barrier, 5 x 28 Instrument/equipment drape, x-ray sox |
H816MBB2930C2 - ProBarrier | 2022-11-03 Environmental surface barrier, 29" x 30" Instrument/equipment drape chair sox |
H816MDC0115S2 - ProBarrier | 2022-11-03 Disposable Bib Chain |
H816MPFL0082 - Shield | 2022-11-03 High-Efficiency Face Mask |
H816MPM10160 - ProView Plus | 2022-11-03 Self Sealing Sterilization Pouch, 10"x 16"https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml# |
H816MPM13180 - ProView Plus | 2022-11-03 Self Sealing Sterilization Pouch, 13" x 18" |