HEPRO.US Standard Surgical Gown L 43gsm 1 Pouch

GUDID 00854427007841

Standard Surgical Gown L 1 Pouch 43gsm A/S SMMS, with two hand paper towels and wrapper, EO Sterile

HEPRO.US INC.

Surgical gown, single-use
Primary Device ID00854427007841
NIH Device Record Keydfcd7759-e064-44f6-8403-58414e522d4b
Commercial Distribution StatusIn Commercial Distribution
Brand NameHEPRO.US Standard Surgical Gown L 43gsm 1 Pouch
Version Model NumberSingle Pouch Standard Surgical gown SMMS
Company DUNS080061451
Company NameHEPRO.US INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100854427007841 [Primary]

FDA Product Code

KKXDrape, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-10-23
Device Publish Date2017-06-20

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00854427007841 - HEPRO.US Standard Surgical Gown L 43gsm 1 Pouch2019-10-23Standard Surgical Gown L 1 Pouch 43gsm A/S SMMS, with two hand paper towels and wrapper, EO Sterile
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