FDA.reportPublic FDA data

CUSTOMED

Primary DI
M2089000120
Brand
CUSTOMED
Company
CUSTOMED INC
Model
712057200012
Catalog number
900012
Device description
OB SURGICAL PACK HOSPITAL SAN CRISTOBAL
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HHDPad, Menstrual, Unscented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HHDPad, Menstrual, UnscentedObstetrics/Gynecology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K902271000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K902271000O. B. PACK ICustomed, Inc.1990-08-15HHD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M2089000122PackageHIBCC4In Commercial Distribution
M2089000120PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Obstetrical/gynaecological surgical procedure kit, medicatedA collection of various sterile surgical instruments, dressings, pharmaceuticals, and materials intended to be used during obstetrical/gynaecological surgery; it is a general-purpose obstetrical/gynaecological surgical kit, and as such is not dedicated to a specific procedure. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in Cool Dry Place

Contacts#

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

Regulatory Flags#

DUNS number
627572217
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
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

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Primary DI, Brand, Company table
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20885380169363CurityCardinal Health 200, LLCHHD2023-08-01
20885380169370CurityCardinal Health 200, LLCHHD2023-08-01
20885380169387CurityCardinal Health 200, LLCHHD2023-08-01
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