FDA.reportPublic FDA data

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

Primary DI
10814125010021
Brand
Professional Medical Surgical Supply, Inc. d / b / a International Direct
Company
PROFESSIONAL MEDICAL-SURGICAL SUPPLY, INCORPORATED
Model
600-NW12
Catalog number
600-NW12
Device description
Embrace Nitrile Exam Gloves - Medium
Published
2020-07-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZAPolymer patient examination glove

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10814125010021PackageGS110In Commercial Distribution
00814125010024PrimaryGS10
00814125011434Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081412501002110814125010021
00814125010024008141250100248141250100240814125010024
00814125011434008141250114348141250114340814125011434

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile examination/treatment glove, non-powdered, non-antimicrobialA device made of nitrile 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 powder and it does not include antimicrobial agents/materials. 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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
042850073
Device count
100
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
00898777001258Professional Medical Surgical Supply, Inc. d / b / a International Direct600-V114600-V1142020-08-12
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

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