FDA.reportPublic FDA data

Hopkins Medical Products®

Primary DI
00817643022265
Brand
Hopkins Medical Products®
Company
HOPKINS UNIFORM COMPANY
Model
690235
Catalog number
690235
Device description
Personal Protection Gown with Thumb Loop
Published
2018-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FYCGOWN, ISOLATION, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYCGown, Isolation, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K941845000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K941845000BUSE STAFF PROTECTION GOWNS AND KITSBusse Hospital Disposables, Inc.1995-05-10FYC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817643022265PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817643022265008176430222658176430222650817643022265

GMDN Terms#

Term, Definition table
TermDefinition
Professional examination gown, single-useA garment made of natural and/or synthetic materials intended to be worn by healthcare providers, sometimes over scrub suits, while examining patients. It can be fluid resistant or impervious to fluid. An examination gown is used during patient examination procedures to protect both the patient and staff from the transfer of contaminants such as microorganisms or body fluids. This is a single-use garment.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)835-1995customerservice@hopkinsmedical.net

Regulatory Flags#

DUNS number
003080678
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817643020421Hopkins Medical Products®6103886103882018-09-28
00817643021701Hopkins Medical Products®7129177129172018-09-28
00817643021718Hopkins Medical Products®7129187129182018-09-28
00817643021732Hopkins Medical Products®34212342122018-09-28
00817643021749Hopkins Medical Products®34213342132018-09-28
00817643022173Hopkins Medical Products®6118066118062018-09-28
00817643022180Hopkins Medical Products®6121456121452018-09-28
00817643022197Hopkins Medical Products®6133036133032018-09-28
00817643020780Hopkins Medical Products®6942626942622018-09-28
00817643020797Hopkins Medical Products®6942636942632018-09-28
00817643020803Hopkins Medical Products®6942656942652018-09-28
00817643020810Hopkins Medical Products®6942726942722018-09-28
00817643020827Hopkins Medical Products®6942736942732018-09-28
00817643020834Hopkins Medical Products®6942756942752018-09-28
00817643020841Hopkins Medical Products®6948626948622018-09-28
00817643020858Hopkins Medical Products®6948636948632018-09-28
00817643020865Hopkins Medical Products®6948656948652018-09-28
00817643020964Hopkins Medical Products®6952626952622018-09-28
00817643020971Hopkins Medical Products®6952636952632018-09-28
00817643021039Hopkins Medical Products®6982876982872018-09-28

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00688162000030ProtexerICP MEDICAL, LLCFYC2025-08-08
00688162290004ProtexerICP MEDICAL, LLCFYC2025-08-08
00688162390506ProtexerICP MEDICAL, LLCFYC2025-08-08
10813360021465ProtexerICP MEDICAL, LLCFYC2025-08-08
00813360021772ProtexerICP MEDICAL, LLCFYC2025-08-08
00842942015175PRIMEDpriMED Medical Products IncFYC2025-07-21
00842942015304PRIMEDpriMED Medical Products IncFYC2025-07-21
10842942015172PRIMEDpriMED Medical Products IncFYC2025-07-21
10842942015301PRIMEDpriMED Medical Products IncFYC2025-07-21
04719882251399CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
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