FDA.reportPublic FDA data

MedSource Rolled Gauze

Primary DI
00816703023518
Brand
MedSource Rolled Gauze
Company
MEDSOURCE INTERNATIONAL LLC
Model
NORTH-042115SWM
Catalog number
Not Applicable
Device description
Bulk Roll Gauze, Sterile
Published
2021-08-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NABGauze / Sponge,Nonresorbable For External Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840155411449PackageGS1100Not in Commercial Distribution
00816703023518PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840155411449008401554114498401554114490840155411449
00816703023518008167030235188167030235180816703023518

GMDN Terms#

Term, Definition table
TermDefinition
Woven gauze roll/sheetA device in the form of a long length of stretchable, absorbent, woven material (e.g., cotton, cellulose), wound into a roll or folded, and typically designed for a variety of applications (non-dedicated) such as a primary wound dressing, dressing retention, and injury padding and compression. It is not a dedicated pressure dressing and does not include latex. This is a single-use device.

Regulatory Flags#

DUNS number
041674552
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840155400108MedSource Non-Rebreather MaskMS-25058-RCSNot Applicable2021-05-26
00840155400184MedSource Non-Rebreather MaskMS-25060-RCSNot Applicable2021-05-27
00840155400375MedSource Oxygen MaskMS-26041-RCSNot Applicable2021-05-28
00840155400412MedSource Oxygen MaskMS-26042-RCSNot Applicable2021-05-28
00840155408425MedSource BlanketMS-40521Not Applicable2021-07-07
00816703023617MedSource First Aid KitNORTH-349000Not Applicable2021-08-17
00816703023723MedSource BagsNORTH-678805EMNot Applicable2021-08-17
00816703023839MedSource First Aid WalletNORTH-67M08Not Applicable2021-08-25
00816703024034MedSource Packed BagsSH-B1311Not Applicable2021-08-25
00840155404304MedSource Body BagsMS-BOD200Not Applicable2021-07-28
00840155406094MedSource Emergency BlanketMS-B100Not Applicable2021-07-27
00840155406162MedSource Emergency BlanketMS-B200Not Applicable2021-07-27
00816703023853MedSource BagsNORTH-67M09Not Applicable2021-08-25
00816703023860MedSource BagsNORTH-67M10Not Applicable2021-08-25
00816703023938MedSource Packed BagsNORTH-90LGTRAUMNot Applicable2021-08-25
00816703023952MedSource Packed BagsNORTH-90TRAUMAENot Applicable2021-08-25
00816703024058MedSource First Aid KitSH-B1411Not Applicable2021-08-25
00816703024065MedSource Packed BagsSH-B1412Not Applicable2021-08-25
00816703027097MedSource BagsMS-TLS-3-BNot Applicable2021-08-16
00816703029473MedSource BagsMS-33360-RCSNot Applicable2021-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D832CFT11PlasdentPLASDENT CORPORATIONNAB2026-10-13
D832FT11PlasdentPLASDENT CORPORATIONNAB2026-10-13
D832SAP21PlasdentPLASDENT CORPORATIONNAB2026-10-13
D832SAP31PlasdentPLASDENT CORPORATIONNAB2026-10-13
D832SAPR21PlasdentPLASDENT CORPORATIONNAB2026-10-13
D832SAPR31PlasdentPLASDENT CORPORATIONNAB2026-10-13
M689HHMTG01020MiniTAC GauzeSafeguard US Operating, LLCNAB2026-10-13
00050428143117CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNAB2026-10-10
00050428339763CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNAB2026-10-10
00050428343869CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNAB2026-10-10
10885380207150CurityCardinal Health 200, LLCNAB2026-10-08
10885380207167CurityCardinal Health 200, LLCNAB2026-10-08
10885380207174CurityCardinal Health 200, LLCNAB2026-10-08
50885380207202CurityCardinal Health 200, LLCNAB2026-10-08
50885380207219CurityCardinal Health 200, LLCNAB2026-10-08
50885380207226CurityCardinal Health 200, LLCNAB2026-10-08
50885380207233CurityCardinal Health 200, LLCNAB2026-10-08
50885380207240CurityCardinal Health 200, LLCNAB2026-10-08
50885380207257CurityCardinal Health 200, LLCNAB2026-10-08
06975675784750RESCUE RESSENTIALSEMSRUN GROUPNAB2026-09-22
00810194401671AiraAIRA, LLCNAB2026-08-26
06979931947972TempoXuchang Zhende Surgical Dressing Co., Ltd.NAB2026-08-21
06979032641168Thomas Jane MedicalHUZHOU JUNDA INDUSTRY CO., LTD.NAB2026-06-27
06979032641175Thomas Jane MedicalHUZHOU JUNDA INDUSTRY CO., LTD.NAB2026-06-27
00197344173993CURADMEDLINE INDUSTRIES, INC.NAB2026-06-24
00197344174006CURADMEDLINE INDUSTRIES, INC.NAB2026-06-24
00840456203330JMUJMU DENTAL, INCNAB2026-06-23
00840456203347JMUJMU DENTAL, INCNAB2026-06-23
00840456203354JMUJMU DENTAL, INCNAB2026-06-23
00840456224199JMUJMU DENTAL, INCNAB2026-06-23