FDA.reportPublic FDA data

Cerdak

Primary DI
58903389005147
Brand
Cerdak
Company
CARBORUNDUM UNIVERSAL LIMITED
Model
Cerdak Aerocloth
Device description
Cerdak Aerocloth 30X30 mm
Published
2018-01-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153138000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153138000Cerdak BasicBu Polysciences Equipment & Trading, LLC2017-06-23FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18903389005149PackageGS110In Commercial Distribution
58903389005147PrimaryGS10
28903389005146Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1890338900514918903389005149
5890338900514758903389005147
2890338900514628903389005146

GMDN Terms#

Term, Definition table
TermDefinition
Wound-nonadherent dressing, absorbent, non-antimicrobialA wound covering typically in the form of a multi-layered pad having a material or substance on its skin-contact surface (e.g., silicone gel), or designed to be soaked in saline prior to application, to prevent adherence to the wound bed thereby decreasing wound trauma potential; it does not contain an antimicrobial agent. It is typically used to absorb wound blood/exudates while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites; it is not a dedicated burn dressing. This is a single-use device.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00STORE IN DRY PLACE IN ANY AMBIENT TEMPERATURE

Contacts#

Phone, Email table
PhoneEmail
3013255574bupet2015@gmail.com

Regulatory Flags#

DUNS number
650051832
Device count
10
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
58903389005024CerdakCerdak Basic 2018-01-11
58903389005031Cerdak Cerdak Basic 2018-01-11
58903389005048CerdakCerdak Basic 2018-01-11
58903389005055CerdakCerdak Basic 2018-01-11
58903389005062CerdakCerdak Basic 2018-01-11
58903389005079CerdakCerdak Basic 2018-01-11
58903389005086CerdakCerdak Basic2018-01-11
58903389005093CerdakCerdak Basic2018-01-11
58903389005109CerdakCerdak Basic2018-01-11
58903389005116CerdakCerdak Basic2018-01-11
58903389005123CerdakCerdak Basic2018-01-11
58903389005130CerdakCerdak Basic2018-01-11
58903389005154CerdakCerdak Aerocloth2018-01-18
58903389005161CerdakCerdak Aerocloth2018-01-18
58903389005178CerdakCerdak Aerocloth2018-01-18
58903389005185CerdakCerdak Aerocloth2018-01-18
58903389005192CerdakCerdak Aerocloth2018-01-18
58903389005208CerdakCerdak Aerocloth2018-01-18
58903389005215CerdakCerdak Aerocloth2018-01-18
58903389005222CerdakCerdak Aerocloth2018-01-18

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