SFT Surgical Gown (Non-Sterile)-XL

GUDID 04710415369406

"The SFT Surgical 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. The SFT Surgical Gown is is made from SPF material, and is full length, constructed with raglan sleeves, hook and loop neck closures, and tie waist closures. 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.

Surgical gown, single-use
Primary Device ID04710415369406
NIH Device Record Keya49e8370-d7eb-4535-af54-f8d37b2b0ef2
Commercial Distribution StatusIn Commercial Distribution
Brand NameSFT Surgical Gown (Non-Sterile)-XL
Version Model NumberJCSG94700XL
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
GS104710415369406 [Primary]
GS114710415369403 [Package]
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

[04710415369406]

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[04710415369406]

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[04710415369406]

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[04710415369406]

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[04710415369406]

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[04710415369406]

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[04710415369406]

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[04710415369406]

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[04710415369406]

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[04710415369406]

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[04710415369406]

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[04710415369406]

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[04710415369406]

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[04710415369406]

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[04710415369406]

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[04710415369406]

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[04710415369406]

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[04710415369406]

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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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