FDA.reportPublic FDA data

Zeni Medical

Primary DI
00324357410054
Brand
Zeni Medical
Company
Focus Health Group, Inc.
Model
410410
Published
2026-04-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MGOClosure, Wound, Adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MGOClosure, Wound, AdhesiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00324357410054PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00324357410054003243574100543243574100540324357410054

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobialA wound covering, typically made of a hydrocolloid, hydrofibre, chitosan or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate; it does not contain an antimicrobial agent. The device assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, paste, or powder. After application, this device cannot be reused.

Regulatory Flags#

DUNS number
826939949
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00324357010155Zeni Medical10015-AG2026-04-13
00324357020451Zeni Medical20045-AG2026-04-13
00324357020680Zeni Medical20068-AG2026-04-13
00324357060440Zeni Medical60044-AG2026-04-13
00324357100252Zeni Medical10025252026-04-13
00324357104045Zeni Medical1000442026-04-13
00324357200457Zeni Medical200452026-04-13
00324357200488Zeni Medical200482026-04-13
00324357200884Zeni Medical200882026-04-13
00324357400482Zeni Medical200482026-04-13
00324357404145Zeni Medical4004142026-04-13
00324357410016Zeni Medical410232026-04-13
00324357410023Zeni Medical4103542026-04-13
00324357410030Zeni Medical410462026-04-13
00324357410047Zeni Medical410482026-04-13
00324357410061Zeni Medical4104142026-04-13
00324357410078Zeni Medical30001H2026-04-13
00324357410085Zeni Medical801442026-04-13
00324357410092Zeni Medical801552026-04-13
00324357410108Zeni Medical810662026-04-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06931132228007SEQUAhold WOUND CLOSURE DEVICEFoshan United Medical Technologies Ltd.MGO2026-05-09
00324357410016Zeni MedicalFocus Health Group, Inc.MGO2026-04-13
00324357410023Zeni MedicalFocus Health Group, Inc.MGO2026-04-13
00324357410030Zeni MedicalFocus Health Group, Inc.MGO2026-04-13
00324357410047Zeni MedicalFocus Health Group, Inc.MGO2026-04-13
00324357410061Zeni MedicalFocus Health Group, Inc.MGO2026-04-13
00850065122076Vitale CELLERA LLCMGO2025-07-17
00869193000002T-STRIPPRECISION MEDICAL DEVICES, LLCMGO2025-06-13
00850005565956VitaleCELLERA LLCMGO2023-02-15
00850005565970VitaleCELLERA LLCMGO2023-02-15
00850031608054VitaleCELLERA LLCMGO2023-02-15
00850031608573Vitale CELLERA LLCMGO2023-02-01
00850031608597Vitale CELLERA LLCMGO2023-02-01
00850031608610Vitale CELLERA LLCMGO2023-02-01
00850005565932VitaleCELLERA LLCMGO2021-11-02
00850005565901VitaleCELLERA LLCMGO2021-10-31
10080196669790MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MGO2021-05-19
40080196669791MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MGO2021-05-19