FDA.reportPublic FDA data

Dr.Med

Primary DI
16958868747005
Brand
Dr.Med
Company
Roosin Medical Co., Ltd.
Model
10cm×10cm
Device description
Xeroform Petrolatum Dressing 10cm×10cm
Published
2022-09-23
Public version status
Update
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
26958868747002PackageGS125In Commercial Distribution
36958868747009PackageGS140In Commercial Distribution
16958868747005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2695886874700226958868747002
3695886874700936958868747009
1695886874700516958868747005

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
10888277415010MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-09-04
10888277415027MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-09-04
00841277111187Novera RenewHarps USA, Inc.FRO2026-08-26
00841277111200Novera RenewHarps USA, Inc.FRO2026-08-26
00841277111224Novera RenewHarps USA, Inc.FRO2026-08-26
00841277111323Novera RenewHarps USA, Inc.FRO2026-08-26
00850087488723CeeportCEEPORT INC.FRO2026-08-26
00850087488730CeeportCEEPORT INC.FRO2026-08-26
00850087488846CeeportCEEPORT INC.FRO2026-08-26
00850087488853CeeportCEEPORT INC.FRO2026-08-26
00850087488747CeeportCEEPORT INC.FRO2026-08-25
04260056880636BactisureOSARTIS GmbHFRO2026-08-25
05000223503284ACTICOAT FlexSMITH & NEPHEW MEDICAL LIMITEDFRO2026-08-25
05000223503697ACTICOAT FlexSMITH & NEPHEW MEDICAL LIMITEDFRO2026-08-25
00197998001369Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998002861Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998173523Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998173554Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998432385Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998432415Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998433559Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
04046961025153Prontosan®B. BRAUN MEDICAL INC.FRO2026-08-09
00050428034873CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-08-08
00050428034880CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-08-08
10197344169429MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-08-07
10197344169436MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-08-07
00818582013796Puracyn® Plus Professional FormulaInnovacyn, Inc.FRO2026-07-31
00818582013802Puracyn® Plus Professional FormulaInnovacyn, Inc.FRO2026-07-31
10197344169405MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-31
00852421007683Pure&CleanPure & Clean, LLCFRO2026-07-29