CustoMed 100770

GUDID 84895237141204

Gown Reinforced Chest & Sleeve A garment made of natural and/or synthetic materials intended to be worn over a scrub suit to cover the arms, trunk, and upper legs, during a surgical procedure; it may be fluid resistant or impervious to fluids. Also known as an operating room (OR) gown, it is used during surgical procedures to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This is a single-use garment.

KENPAX INTERNATIONAL LIMITED

Surgical gown, single-use
Primary Device ID84895237141204
NIH Device Record Key5f13c112-4372-4d5c-98ed-ddf0f4b5a282
Commercial Distribution StatusIn Commercial Distribution
Brand NameCustoMed
Version Model Number1
Catalog Number100770
Company DUNS686206765
Company NameKENPAX INTERNATIONAL LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104895237141208 [Primary]
GS184895237141204 [Package]
Contains: 04895237141208
Package: CASE [30 Units]
In Commercial Distribution

FDA Product Code

FYAGown, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-24
Device Publish Date2020-07-16

On-Brand Devices [CustoMed]

84895237141105Lab coat
84895237141099Lab coat
84895237141082Lab coat
84895237141075Lab coat
84895237141068Lab coat
84895237141051Lab coat
74895237141047Lab coat
74895237141030Lab coat
84895237141150Surgical cap A non-sterile head covering designed as a cap intended to be worn by surgical staff
84895237141143Bouffant cap A non-sterile head covering designed as a cap intended to be worn by surgical staff
84895237141136Bouffant cap A non-sterile head covering designed as a cap intended to be worn by surgical staff
74895237104127Shoe cover A non-sterile device made of a non-conductive material intended to be used as a phys
84895237141112Shoe cover A non-sterile device made of a non-conductive material intended to be used as a physi
84895237141228GOWN SURGICAL POLY-REINFORCED SOFT A garment made of natural and/or synthetic materials intende
84895237141211GOWN SURGICAL POLY-REINFORCED SOFT A garment made of natural and/or synthetic materials intende
84895237141204Gown Reinforced Chest & Sleeve A garment made of natural and/or synthetic materials intended to
84895237141198Gown No Reinforced
84895237141181Gown Reinforced Chest & Sleeve
84895237141174Gown Reinforced Chest & Sleeve
84895237141167Gown Reinforced Chest & Sleeve
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