FDA.reportPublic FDA data

Medline

Primary DI
10080196669837
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
MSC6144
Catalog number
MSC6144
Device description
"GAUZE,HYDROGEL,SKINTEGRITY,4""X4"""
Published
2021-08-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MGQDressing, wound and burn, hydrogel w/drug and/or biologic
NAEDressing, wound, hydrogel without drug and/or biologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or BiologicUnknownU
NAEDressing, Wound, Hydrogel Without Drug And/Or BiologicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40080196669838PackageGS130In Commercial Distribution
10080196669837PrimaryGS10
00080196669830Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
4008019666983840080196669838
1008019666983710080196669837
00080196669830000801966698300801966698300080196669830

GMDN Terms#

Term, Definition table
TermDefinition
Wound hydrogel dressing, non-antimicrobialA wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases; it does not include an antimicrobial agent(s). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
2
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10197344144181MEDLINERTACIBDHPRTACIBDHP2026-08-07
10197344169429MEDLINEMSCSRG97310MSCSRG973102026-08-07
10197344169436MEDLINEMSCSRG97314MSCSRG973142026-08-07
10195327188955NAMICDYNJGWIRE20LDYNJGWIRE20L2022-08-04
10195327279776MedlineDNSC145169DNSC1451692023-06-13
10195327301057NAMICDYNJHWIRE100DYNJHWIRE1002023-01-29
10195327301590NAMICDYNJHWIRE101DYNJHWIRE1012023-01-29
10195327301606NAMICDYNJHWIRE102DYNJHWIRE1022023-01-29
10195327301613NAMICDYNJHWIRE103DYNJHWIRE1032023-01-29
10195327301620NAMICDYNJHWIRE104DYNJHWIRE1042023-01-29
10195327301637NAMICDYNJHWIRE105DYNJHWIRE1052023-01-29
10195327302153NAMICDYNJHWIRE106DYNJHWIRE1062023-01-29
10195327302184NAMICDYNJHWIRE107DYNJHWIRE1072023-01-29
10195327302191NAMICDYNJHWIRE108DYNJHWIRE1082023-01-29
10195327302207NAMICDYNJHWIRE109DYNJHWIRE1092023-01-29
10195327302214NAMICDYNJHWIRE110DYNJHWIRE1102023-01-29
10195327305987NAMICDYNJHWIRE111DYNJHWIRE1112023-01-29
10195327305994NAMICDYNJHWIRE112DYNJHWIRE1122023-01-29
10195327306007NAMICDYNJHWIRE113DYNJHWIRE1132023-01-29
10195327306014NAMICDYNJHWIRE114DYNJHWIRE1142023-05-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00370275900801PerioStomForward Science Technologies LLCMGQ2026-08-07
08809319802631HyFer HerNonMOON-X USA, Inc.NAE2026-08-03
00850083365011LaviorLavior Pharma Inc.NAE2026-07-17
00850083365028LaviorLavior Pharma Inc.NAE2026-07-17
06970206829191PreviClear Border Sacrum Transparent Gel DressingJiangsu NewValue Medical Products Co.,Ltd.NAE2026-06-23
06970206829207PreviClear Border Sacrum Transparent Gel DressingJiangsu NewValue Medical Products Co.,Ltd.NAE2026-06-23
06970206820808kegel Hydrogel DressingJiangsu NewValue Medical Products Co.,Ltd.NAE2026-06-22
01714196112452DermaRite Medical Wound Gel- Amorphous HydrogelSion Brands LLCNAE2026-06-01
00368040753141Promiseb Topical CreamPrimus Pharmaceuticals, Inc.MGQ2026-05-01
10840330704936ProCureTwin Med, LLCNAE2026-04-22
10840330704943ProCureTwin Med, LLCNAE2026-04-22
10840330705803ProCureTwin Med, LLCNAE2026-04-22
10840330705810ProCureTwin Med, LLCNAE2026-04-22
10840330706350ProCureTwin Med, LLCNAE2026-04-22
00324357010155Zeni MedicalFocus Health Group, Inc.NAE2026-04-13
00324357100252Zeni MedicalFocus Health Group, Inc.NAE2026-04-13
00324357104045Zeni MedicalFocus Health Group, Inc.NAE2026-04-13
00743537000456First ResponderWATER-JEL TECHNOLOGIES, L.L.C.NAE2026-02-19
00743537000470MilitaryWATER-JEL TECHNOLOGIES, L.L.C.NAE2026-02-19
10197344017508MEDLINEMEDLINE INDUSTRIES, INC.NAE2025-10-23
20192253040156KendallCardinal Health 200, LLCNAE2025-09-26
00197998326882Solventum™ Nu-Gel™Solventum Germany GmbHNAE2025-09-22
00197998326967Solventum™ Nu-Gel™Solventum Germany GmbHNAE2025-09-22
15056860000034Gentell Hydrogel Sheet DressingGentell, LLCNAE2025-08-21
15056860000041Gentell Hydrogel Sheet DressingGentell, LLCNAE2025-08-21
15056860000058Gentell Hydrogel Sheet DressingGentell, LLCNAE2025-08-21
10197344110162MEDLINEMEDLINE INDUSTRIES, INC.NAE2025-08-04
M689HHWSK02050Wound Seal KitSafeguard US Operating, LLCNAE2025-06-24
00810040134692SimpuritySAFE N' SIMPLE LLCNAE2025-06-17
00810040134708SimpuritySAFE N' SIMPLE LLCNAE2025-06-17