FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50885380052338
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
C-WNM383
Catalog number
C-WNM383
Device description
OIL EMULSION DRESSING, 3X8IN, STER
Published
2019-05-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GERGAUZE, EXTERNAL (WITH DRUG/BIOLOGIC/ANIMAL SOURCE MATERIAL)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GERGAUZE, EXTERNAL (WITH DRUG/BIOLOGIC/ANIMAL SOURCE MATERIAL)

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K921290000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K921290000INMAN MEDICAL OIL EMULSION DRESSINGInman Medical Corp.1992-11-23FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20885380052337PackageGS136In Commercial Distribution
50885380052338PackageGS16In Commercial Distribution
10885380052330PrimaryGS10
70885380052332Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088538005233720885380052337
5088538005233850885380052338
1088538005233010885380052330
7088538005233270885380052332

GMDN Terms#

Term, Definition table
TermDefinition
Petrolatum woven gauze pad, sterileA sterile, 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
3
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10198956037908CARDINAL HEALTH08-3641G08-3641G2026-09-04
10198956210240CARDINAL HEALTHAMN213116EAMN213116E2026-09-04
10198956310933CARDINAL HEALTHANE439532GANE439532G2026-09-04
10198956331891CARDINAL HEALTHSAN13ARBIFSAN13ARBIF2026-09-04
10198956333420CARDINAL HEALTHSANX4IPSSCSANX4IPSSC2026-09-04
10198956359291CARDINAL HEALTHSMA54BGEVCSMA54BGEVC2026-09-04
10198956379084CARDINAL HEALTHSOP33EXMSGSOP33EXMSG2026-09-04
10198956395947CARDINAL HEALTHSOPMIMPMSBSOPMIMPMSB2026-09-04
10198956398467CARDINAL HEALTHSBA44LPCEASBA44LPCEA2026-09-04
10198956415195CARDINAL HEALTHSCVCGOHILHSCVCGOHILH2026-09-04
10198956421462CARDINAL HEALTHSOPMVSAUCJSOPMVSAUCJ2026-09-04
10198956426061CARDINAL HEALTHSCVDKMVOGDSCVDKMVOGD2026-09-04
10198956428102CARDINAL HEALTHSAN13RDEMSSAN13RDEMS2026-09-04
10198956454989CARDINAL HEALTHSOP23KPNLCSOP23KPNLC2026-09-04
10198956462977CARDINAL HEALTHSBA48LCRHCSBA48LCRHC2026-09-04
10198956463394CARDINAL HEALTHSEN23TAPCLSEN23TAPCL2026-09-04
10198956464520CARDINAL HEALTHSMA23GPNVBSMA23GPNVB2026-09-04
10198956465510CARDINAL HEALTH34-3217C34-3217C2026-09-04
10198956468399CARDINAL HEALTHPO1DTHAMQPO1DTHAMQ2026-09-04
10198956468481CARDINAL HEALTHSMAOCGLSTGSMAOCGLSTG2026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20612479198559McKessonMCKESSON MEDICAL-SURGICAL INC.GER2020-06-09
10612479198514McKessonMCKESSON MEDICAL-SURGICAL INC.GER2020-06-09
40612479198539McKessonMCKESSON MEDICAL-SURGICAL INC.GER2020-06-09
40612479198560McKessonMCKESSON MEDICAL-SURGICAL INC.GER2020-06-09
10612479198576McKessonMCKESSON MEDICAL-SURGICAL INC.GER2020-05-18
10612479198606McKessonMCKESSON MEDICAL-SURGICAL INC.GER2020-05-18
40612479198591McKessonMCKESSON MEDICAL-SURGICAL INC.GER2020-05-18
40612479198621McKessonMCKESSON MEDICAL-SURGICAL INC.GER2020-05-18
00888499000929CARDINAL HEALTHCardinal Health 200, LLCGER2019-10-14
00888499000936CARDINAL HEALTHCardinal Health 200, LLCGER2019-10-14
10885380052224CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
10885380052231CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
10885380052248CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
10885380052262CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
10885380052279CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
10885380052286CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
10885380052293CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
10885380052309CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
10885380052316CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
10885380052323CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
10885380052330CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
50885380052222CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
50885380052239CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
20885380052245CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
50885380052260CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
20885380052276CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
50885380052284CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
50885380052291CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
50885380052307CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
50885380052314CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29