FDA.reportPublic FDA data

Polynew

Primary DI
16958868747050
Brand
Polynew
Company
Roosin Medical Co., Ltd.
Model
5cm×5cm
Device description
Xeroform Petrolatum Dressing 5cm×5cm
Published
2023-02-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K181478000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181478000Roosin Xeroform Petrolatum DressingRoosin Medical Co., Ltd.2019-09-13FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26958868747057PackageGS128In Commercial Distribution
36958868747054PackageGS1120In Commercial Distribution
16958868747050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2695886874705726958868747057
3695886874705436958868747054
1695886874705016958868747050

GMDN Terms#

Term, Definition table
TermDefinition
Petrolatum woven gauze padA non-medicated device in the form of a patch or swab (also referred to as a sponge) made from woven material (e.g., cotton, cellulose) and primarily designed to absorb fluids for medical purposes; it is impregnated with petrolatum to increase its nonadherent properties. The device is typically used to clean, cover, or pack wounds, abrasions or burns and absorb their exudates, or to absorb body-surface exudates; it is not however a dedicated burn dressing. This is a single-use device.

Regulatory Flags#

DUNS number
527587815
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16958868742147Vipflge5cm×5cm2022-09-23
16958868742154Dr.Med10cm×10cm2023-02-08
16958868752030OPTITEKNIK3cm×4cm2026-04-29
16958868743069Biokerzon10cm×10cm2026-04-27
16958868743090Polynew5cm×6m2026-04-27
16958868752023ROOSIN11cm×11cm2026-04-27
16958868753006ROOSINAdhesive 11cm×25cm2026-04-27
16958868753013ROOSINAdhesive 10cm×10cm2026-04-27
16958868753020ROOSINNon-adhesive 10cm×10cm2026-04-27
16958868752016Biokerzon10cm×10cm2026-04-17
16958868744004Dr.Med10cm×10cm2022-09-23
16958868744011Polynew10cm×10cm2022-09-23
16958868743021Dr.Med5cmX5cm2024-05-13
16958868743038Dr.Med15cm×15cm2024-05-13
16958868743045Polynew5cm×5cm2024-05-13
16958868743052Polynew5cm×7.5cm2024-05-13
26958868743028Dr.Med5cmX5cm2024-05-13
26958868743035Dr.Med15cm×15cm2024-05-13
26958868743042Polynew5cm×5cm2024-05-13
26958868743059Polynew5cm×7.5cm2024-05-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00852421007300Pure&CleanPure & Clean, LLCFRO2026-07-22
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00818582012881Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002451Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002475Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002536Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
10197344169450MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-17
09551012610479ELECTROCYN somaV3BIO SDN. BHD.FRO2026-07-16
10197344176007MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
10197344176014MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
10197344176021MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
10197344176038MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
04260056880650BLASTXOSARTIS GmbHFRO2026-07-12
00850088144604CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850088144611CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850088144628CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850088144635CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850019138146SilverSealNEXGEL Inc.FRO2026-07-08
00850019138153TurfGuardNEXGEL Inc.FRO2026-07-08
00850019138443SilverSealNEXGEL Inc.FRO2026-07-08
00850019138474SilverSealNEXGEL Inc.FRO2026-07-08
00850019138511SilverSealNEXGEL Inc.FRO2026-07-08
00850067990086Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990178Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990260Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990352Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990444Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990536Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990628Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990710Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06