FDA.reportPublic FDA data

Zeni Medical

Primary DI
00324357410061
Brand
Zeni Medical
Company
Focus Health Group, Inc.
Model
410414
Published
2026-04-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
30324357410062PackageGS110In Commercial Distribution
50324357410066PackageGS120In Commercial Distribution
00324357410061PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3032435741006230324357410062
5032435741006650324357410066
00324357410061003243574100613243574100610324357410061

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
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
false
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
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
00324357404145Zeni Medical4004142026-04-13
00324357410016Zeni Medical410232026-04-13
00324357410023Zeni Medical4103542026-04-13
00324357410030Zeni Medical410462026-04-13
00324357410047Zeni Medical410482026-04-13
00324357410054Zeni Medical4104102026-04-13
00324357410078Zeni Medical30001H2026-04-13
00324357410085Zeni Medical801442026-04-13
00324357410092Zeni Medical801552026-04-13
00324357410108Zeni Medical810662026-04-13
00324357410115Zeni Medical80177S2026-04-13

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
00324357410054Zeni 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