Primary Device ID | D7664334692 |
NIH Device Record Key | 827cf8fc-47ef-40cd-8446-bee5efa7aaf7 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Le soothe Polychloroprene Sapphire PF EXAM LG |
Version Model Number | 433469 |
Catalog Number | 433469 |
Company DUNS | 061081477 |
Company Name | Smarthealth, Inc. |
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 | true |
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 |
---|---|
HIBCC | D7664334690 [Unit of Use] |
HIBCC | D7664334691 [Primary] |
HIBCC | D7664334692 [Package] Contains: D7664334691 Package: case [12 Units] In Commercial Distribution |
LZA | Polymer Patient Examination Glove |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-12-06 |
Device Publish Date | 2022-11-28 |
D7664311062 - REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM XS | 2023-08-15 GLV REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM XS*200 |
D7664311072 - REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM SM | 2023-08-15 GLV REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM SM*200 |
D7664311082 - REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM MED | 2023-08-15 GLV REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM MED*200 |
D7664311092 - REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM LG | 2023-08-15 GLV REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM LG*200 |
D7664311102 - REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM XL | 2023-08-15 GLV REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM XL*200 |
D766408712 - QUALITOUCH LATEX PF EXAM NATURAL CF XS* | 2023-07-26 GLV QUALITOUCH LATEX PF EXAM NATURAL CF XS*100 |
D766408722 - QUALITOUCH LATEX PF EXAM NATURAL CF SM | 2023-07-26 GLV QUALITOUCH LATEX PF EXAM NATURAL CF SM*100 |
D766408732 - QUALITOUCH LATEX PF EXAM NATURAL CF MD | 2023-07-26 GLV QUALITOUCH LATEX PF EXAM NATURAL CF MED*100 |