FDA.reportPublic FDA data

CUSTOMED

Primary DI
M2089000812
Brand
CUSTOMED
Company
CUSTOMED INC
Model
712057470020
Catalog number
900081
Device description
"STERILIZATION WRAPPER DISPOSABLE 20"" X 20"""
Published
2016-09-23
Public version status
Update
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
FRGWrap, Sterilization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K953678000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K953678000STERIMED STERIZATION WRAPPER (NON-STERILE)Customed, Inc.1995-10-02FRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M2089000812PrimaryHIBCC0
M2089000810Unit of UseHIBCC0

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
787-622-5151customer.service@customedhealing.com

Regulatory Flags#

DUNS number
627572217
Device count
1000
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M2089004048C1CUSTOMED7120577000489004048C2023-08-10
M2089004049C1CUSTOMED7120577000499004049C2023-08-10
M2089004050C1CUSTOMED7120577000509004050C2023-08-10
M2089004051C1CUSTOMED7120577000519004051C2023-08-10
M20810063642CUSTOMEDOR TURNOVER DRAPE WITH TRANSFER SHEET10063642023-08-10
M20890029842CUSTOMED71205710298490029842023-08-10
M20890029852CUSTOMED71205710298590029852023-08-10
M20890029862CUSTOMED71205710298690029862023-08-10
M20890029872CUSTOMED71205710298790029872023-08-10
M20890029882CUSTOMED71205710298890029882023-08-10
M20890030922CUSTOMED71205710309290030922023-08-10
M20890030932CUSTOMED71205710309390030932023-08-10
M20890031442CUSTOMED71205710314490031442023-08-10
M20890040522CUSTOMED71205710405290040522023-08-10
M20890046941CUSTOMED71205701469490046942023-08-10
M20890046951CUSTOMED71205701469590046952023-08-10
M20810063640CUSTOMEDOR TURNOVER DRAPE WITH TRANSFER SHEET10063642023-08-10
M20890029840CUSTOMED71205710298490029842023-08-10
M20890029850CUSTOMED71205710298590029852023-08-10
M20890029860CUSTOMED71205710298690029862023-08-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20680651497639HalyardO&M HALYARD, INC.FRG2026-07-16
20680651497646HalyardO&M HALYARD, INC.FRG2026-07-16
20680651497653HalyardO&M HALYARD, INC.FRG2026-07-16
20680651497660HalyardO&M HALYARD, INC.FRG2026-07-16
20680651497677HalyardO&M HALYARD, INC.FRG2026-07-16
20680651497684HalyardO&M HALYARD, INC.FRG2026-07-16
00859464007731Turbett Surgical, Inc.Turbett Surgical IncFRG2026-07-14
00859464007748Turbett Surgical, Inc.Turbett Surgical IncFRG2026-07-14
08404535030761Brasseler USAPeter Brasseler Holdings, LLCFRG2026-07-13
08404535030792Brasseler USAPeter Brasseler Holdings, LLCFRG2026-07-13
00840456206881JMUJMU DENTAL, INCFRG2026-07-08
00840456206898JMUJMU DENTAL, INCFRG2026-07-08
00840456206928JMUJMU DENTAL, INCFRG2026-07-08
10686864061868MEDICOM SAFESEALAMD Medicom IncFRG2026-06-25
10686864061875MEDICOM SAFESEALAMD Medicom IncFRG2026-06-25
10686864061899MEDICOM SAFESEALAMD Medicom IncFRG2026-06-25
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10686864061912MEDICOM SAFESEALAMD Medicom IncFRG2026-06-25
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00850088572056Arrigo Professional Supplies LLCARRIGO PROFESSIONAL SUPPLIES LLCFRG2026-06-22
00850088572063Arrigo Professional Supplies LLCARRIGO PROFESSIONAL SUPPLIES LLCFRG2026-06-22
00850088572070Arrigo Professional Supplies LLCARRIGO PROFESSIONAL SUPPLIES LLCFRG2026-06-22
00842942013485PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942013645PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942013652PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942013669PRIMEDpriMED Medical Products IncFRG2026-06-04