FDA.reportPublic FDA data

Zeni Medical

Primary DI
00324357410047
Brand
Zeni Medical
Company
Focus Health Group, Inc.
Model
41048
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
00324357410047PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00324357410047003243574100473243574100470324357410047

GMDN Terms#

Term, Definition table
TermDefinition
Wound-nonadherent dressing, permeable, non-antimicrobialA wound covering typically in the form of a porous material (e.g., a fine mesh) impregnated/coated with a substance (e.g., petrolatum, silicone) or made of a material that prevents adherence to the wound bed, thereby decreasing the potential for trauma to the wound and surrounding skin upon removal; it does not contain an antimicrobial agent. Its pores permit the drainage of exudates from, and application of medication to, the wound. It may be used with other wound-care products for chronic and postoperative wounds, burns, skin graft fixation/cultured-cell carrier, cuts, or abrasions; it is neither a dedicated burn dressing nor gauze. This is a single-use device.

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
00324357410054Zeni Medical4104102026-04-13
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
00324357410054Zeni 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