FDA.reportPublic FDA data

Gentell

Primary DI
06948909462250
Brand
Gentell
Company
Shaoxing Haoshide Medical Products Co., Ltd.
Model
GEN-15480
Device description
BORDERED GAUZE, nonwoven dressing 10x20cm
Published
2026-08-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NACDressing, Wound, Hydrophilic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06948909462267PackageGS125In Commercial Distribution
06948909462274PackageGS14In Commercial Distribution
06948909462250PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06948909462267069489094622676948909462267
06948909462274069489094622746948909462274
06948909462250069489094622506948909462250

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic polymer semi-permeable film dressing, adhesiveA transparent, semi-permeable (i.e., impermeable to fluids, permeable to vapours and gases) covering applied to wounded or diseased tissue intended to provide protection (e.g., from dirt, water) and/or promote healing. It is a thin, clear film made of synthetic polymer material that is covered on one side with a pressure-sensitive adhesive. It may be applied directly to tissue or used in combination with other dressings (e.g., gauze) to protect postsurgical incisions and minor wounds (e.g., cuts, scrapes, burns, skin tears, blisters). It may also be used to secure to skin other devices such as vascular catheters, infusion ports, or tubing. This is a single-use device.

Regulatory Flags#

DUNS number
420764429
Device count
1
DM exempt
false
Premarket exempt
true
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
06948909456020N/AP169C1BK2024-11-25
06948909456044N/AP169C2BK2024-11-25
06948909456068N/AP169C3BK2024-11-25
06948909456082N/AP169C4BK2024-11-25
06948909456105N/AP169C5BK2024-11-25
06948909456129N/AP169C6BK2024-11-25
06948909456143N/AP169C20BK2024-11-25
06948909456181N/AP169C22BK2024-11-25
06948909456204N/AP169C23BK2024-11-25
06948909456228N/AP169C24BK2024-11-25
06948909456242N/AP169C15BK2024-11-25
06948909456280N/AP169C17BK2024-11-25
06948909456303N/AP169C18BK2024-11-25
06948909456327N/AP169C19BK2024-11-25
06948909456341N/AP169C25BK2024-11-25
06948909456365N/AP169C26BK2024-11-25
06948909456389N/AP169C27BK2024-11-25
06948909456402N/AP169C28BK2024-11-25
06948909456426N/AP169C29BK2024-11-25
06948909456440N/AP169C32BK2024-11-25

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Primary DI, Brand, Company table
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00197998367427Solventum™ Adaptic™Solventum Germany GmbHNAC2026-08-26
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00197998152283Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998152313Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
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00197998305801Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
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00197998305986Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
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00197998419010Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998419058Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998419829Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
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