FDA.reportPublic FDA data

KIMGUARD™ KC100 Sterilization Wrap

Primary DI
00036000107128
Brand
KIMGUARD™ KC100 Sterilization Wrap
Company
KIMBERLY-CLARK GLOBAL SALES, LLC
Model
10712
Device description
12" x 12" Sterilization Wrap
Published
2016-11-30
Public version status
Update
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
FRGWrap, sterilization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10036000107125PackageGS12In Commercial Distribution
00036000107128PrimaryGS10
90036000107121Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1003600010712510036000107125
00036000107128000360001071280360001071280036000107128
9003600010712190036000107121

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization packaging, single-useA device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)346-4652xxx@xxx.xxx

Regulatory Flags#

DUNS number
830997032
Device count
500
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
10036000628705Kimtech Element Nitrile Exam Gloves (XS)6287062870-002021-07-14
10036000628712Kimtech Element Nitrile Exam Gloves (S)6287162871-002021-07-14
10036000628729Kimtech Element Nitrile Exam Gloves (M)6287262872-002021-07-14
10036000628736Kimtech Element Nitrile Exam Gloves (L)6287362873-002021-07-14
10036000628743Kimtech Element Nitrile Exam Gloves (XL)6287462874-002021-07-14
10036000628606Kimtech Opal Nitrile Exam Gloves (XS)6286062860-002021-05-10
10036000628613Kimtech Opal Nitrile Exam Gloves (S)6286162861-002021-05-10
10036000628620Kimtech Opal Nitrile Exam Gloves (M)6286262862-002021-05-10
10036000628637Kimtech Opal Nitrile Exam Gloves (L)6286362863-002021-05-10
10036000628644Kimtech Opal Nitrile Exam Gloves (XL)6286462864-002021-05-10
10036000628255KIMTECH VISTA NITRILE EXAM (XS)6282562825-002021-04-15
10036000628262KIMTECH VISTA NITRILE EXAM (S)6282662826-002021-04-15
10036000628279KIMTECH VISTA NITRILE EXAM (M)6282762827-002021-04-15
10036000628286KIMTECH VISTA NITRILE EXAM (L)6282862828-002021-04-15
10036000628293KIMTECH VISTA NITRILE EXAM (XL)6282962829-002021-04-15
10036000682318KIMTECH LATEX POWDER FREE EXAM GLOVES (S)6283162831-002021-02-01
10036000682325KIMTECH LATEX POWDER FREE EXAM GLOVES (M)6283262832-002021-02-01
10036000682332KIMTECH LATEX POWDER FREE EXAM GLOVES (L)6283362833-002021-02-01
10036000682349KIMTECH LATEX POWDER FREE EXAM GLOVES (XL)6283462834-002021-02-01
10036000519409Kimtech Prizm Neoprene Nitrile Exam Gloves (XS)5194051940-002020-12-30

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