FDA.reportPublic FDA data

Cerdak

Primary DI
58903389005185
Brand
Cerdak
Company
CARBORUNDUM UNIVERSAL LIMITED
Model
Cerdak Aerocloth
Device description
Cerdak Aerocloth 45 x 150 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
18903389005187PackageGS110In Commercial Distribution
58903389005185PrimaryGS10
28903389005184Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1890338900518718903389005187
5890338900518558903389005185
2890338900518428903389005184

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
58903389005147CerdakCerdak Aerocloth2018-01-18
58903389005154CerdakCerdak Aerocloth2018-01-18
58903389005161CerdakCerdak Aerocloth2018-01-18
58903389005178CerdakCerdak Aerocloth2018-01-18
58903389005192CerdakCerdak Aerocloth2018-01-18
58903389005208CerdakCerdak Aerocloth2018-01-18
58903389005215CerdakCerdak Aerocloth2018-01-18
58903389005222CerdakCerdak Aerocloth2018-01-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10080196415397MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277415386MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277415393MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277677289MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277677296MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10197344175994MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-20
09551012610035ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
09551012610196ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
09551012610363ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
09551012610370ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
10192253046403KendallCardinal Health 200, LLCFRO2026-03-25
10192253046519KendallCardinal Health 200, LLCFRO2026-03-25
09120073781536GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781543GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781550GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781567GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781574GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
10197344169412MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-12-05
10197344169443MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-12-05
10197344169467MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07
10197344169474MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07
10197344169481MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07
10197344169498MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07
10197344169504MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07
10197344170197MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-10-13
10192253046274KendallCardinal Health 200, LLCFRO2025-09-22
10192253047837XeroformCardinal Health 200, LLCFRO2025-09-22
10192253047844XeroformCardinal Health 200, LLCFRO2025-09-22
10192253047851XeroformCardinal Health 200, LLCFRO2025-09-22
10192253047868XeroformCardinal Health 200, LLCFRO2025-09-22