Primary Device ID | 20813172022572 |
NIH Device Record Key | ab242be8-c5fc-4036-94a0-5a33977328e3 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Prestige® Chloroprene |
Version Model Number | 134550 |
Company DUNS | 802020693 |
Company Name | INNOVATIVE HEALTHCARE CORPORATION |
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 | false |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00813172022578 [Unit of Use] |
GS1 | 10813172022575 [Primary] |
GS1 | 20813172022572 [Package] Contains: 10813172022575 Package: 100 pr/bx, 4 bx/cs [4 Units] In Commercial Distribution |
KGO | Surgeon'S Gloves |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2023-05-03 |
Device Publish Date | 2022-12-08 |
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10813172020328 - NitriDerm® Ultra Pro™ | 2024-05-21 Gloves, Exam, Nitrile, Chemo, Non-Sterile, Powder-Free, Textured, Cobalt Blue, 5.1 mil, XXL |
10813172020502 - NitriDerm® Ultra Orange™ | 2024-05-21 Gloves, Exam, Nitrile, Non-Sterile,Powder-Free, Textured, Orange, XXL |
10813172020519 - NitriDerm® Ultra Orange™ | 2024-05-21 Gloves, Exam, Nitrile, Non-Sterile,Powder-Free, Textured, Orange, XXXL |
10813172020939 - NitriDerm® EP Orange® | 2024-05-21 Gloves, Exam, Nitrile, Chemo, Non-Sterile, Powder-Free, Textured, Ext Cuff, Orange, 6.5 mil, XXL |
10813172020946 - NitriDerm® EP Orange® | 2024-05-21 Gloves, Exam, Nitrile, Chemo, Non-Sterile, Powder-Free, Textured, Ext Cuff, Orange, 6.5 mil, XXXL |