SMS Reinforced Surgical Gown (Non-Sterile)-L

GUDID 14710415369151

The SMS Reinforced Gown is a device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. It is made from SMS material, and is full length, constructed with raglan sleeves, hook and loop neck closures, and tie waist closures. The reinforcement has the following structural features: (a) The chest area is reinforced with additional layer of SMS material. (b) The sleeve area is reinforced with additional layer of SMS material. Non-sterile surgical gowns are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Gowns are to be sold directly to users after EtO sterilization validation to ISO 11135.

MEDTECS (TAIWAN) CORP.

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Primary Device ID14710415369151
NIH Device Record Key2d94f6d7-b384-49aa-9a85-584155ce3f6d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSMS Reinforced Surgical Gown (Non-Sterile)-L
Version Model NumberJCSG74700L
Company DUNS658023890
Company NameMEDTECS (TAIWAN) CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS104710415369154 [Primary]
GS114710415369151 [Package]
Contains: 04710415369154
Package: Carton [25 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FYAGown, Surgical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[14710415369151]

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[14710415369151]

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[14710415369151]

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[14710415369151]

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[14710415369151]

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[14710415369151]

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[14710415369151]

Ethylene Oxide

[14710415369151]

Ethylene Oxide

[14710415369151]

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[14710415369151]

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[14710415369151]

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Ethylene Oxide

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-04
Device Publish Date2020-11-26

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