FDA.reportPublic FDA data

Professional Medical Surgical Supply, Inc. d / b / a International Direct

Primary DI
00898777001258
Brand
Professional Medical Surgical Supply, Inc. d / b / a International Direct
Company
PROFESSIONAL MEDICAL-SURGICAL SUPPLY, INCORPORATED
Model
600-V114
Catalog number
600-V114
Device description
Compliance Synthetic Vinyl Gloves - X Large 150 ct boxes
Published
2020-08-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LYZVinyl patient examination glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYZVinyl Patient Examination GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10898777001255PackageGS110In Commercial Distribution
00898777001258PrimaryGS10
00814125011533Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1089877700125510898777001255
00898777001258008987770012588987770012580898777001258
00814125011533008141250115338141250115330814125011533

GMDN Terms#

Term, Definition table
TermDefinition
Vinyl examination/treatment glove, non-powderedA non-sterile device made of vinyl intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with talcum powder and it does not have antimicrobial features. The device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)648-5190ksimanis@promedsupply.com

Regulatory Flags#

DUNS number
042850073
Device count
150
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00898777001227Professional Medical Surgical Supply, Inc. d / b / a International Direct600-V111600-V1112020-08-12
00898777001234Professional Medical Surgical Supply, Inc. d / b / a International Direct600-V112600-V1122020-08-12
00898777001241Professional Medical Surgical Supply, Inc. d / b / a International Direct600-V113600-V1132020-08-12
20898777001221Professional Medical Surgical Supply, Inc. d / b / a International Direct600-V111600-V1112020-08-12
10898777001231Professional Medical Surgical Supply, Inc. d / b / a International Direct600-V112600-V1122020-08-12
10898777001248Professional Medical Surgical Supply, Inc. d / b / a International Direct600-V113600-V1132020-08-12
10898777001255Professional Medical Surgical Supply, Inc. d / b / a International Direct600-V114600-V1142020-08-12
00814125010871Professional Medical Surgical Supply, Inc. d / b / a International Direct600-V111-BX600-V111-BX2020-07-24
00814125010888Professional Medical Surgical Supply, Inc. d / b / a International Direct600-V112-BX600-V112-BX2020-07-24
00814125010895Professional Medical Surgical Supply, Inc. d / b / a International Direct600-V113-BX600-V113-BX2020-07-24
00814125010901Professional Medical Surgical Supply, Inc. d / b / a International Direct600-V114-BX600-V114-BX2020-07-24
00814125010024Professional Medical Surgical Supply, Inc. d / b / a International Direct600-NW12600-NW122020-07-24
00814125010031Professional Medical Surgical Supply, Inc. d / b / a International Direct600-NW13600-NW132020-07-24
00814125010048Professional Medical Surgical Supply, Inc. d / b / a International Direct600-NW14600-NW142020-07-24
00814125010475Professional Medical Surgical Supply, Inc. d / b / a International Direct600-NW11600-NW112020-07-24
00898777001340Professional Medical Surgical Supply, Inc. d / b / a International Direct600-SS11600-SS112020-07-24
00898777001944Professional Medical Surgical Supply, Inc. d / b / a International Direct600-SS12600-SS122020-07-24
00898777001951Professional Medical Surgical Supply, Inc. d / b / a International Direct600-SS13600-SS132020-07-24
00898777001968Professional Medical Surgical Supply, Inc. d / b / a International Direct600-SS14600-SS142020-07-24
10814125010021Professional Medical Surgical Supply, Inc. d / b / a International Direct600-NW12600-NW122020-07-24

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