FDA.reportPublic FDA data

FloraSeal

Primary DI
M495FS250D1
Brand
FloraSeal
Company
ADHEZION BIOMEDICAL, LLC
Model
FS250D
Catalog number
FS-250D
Device description
FloraSeal Microbial Sealant
Published
2016-11-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NZPSealant, Microbial

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NZPSealant, MicrobialGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083354000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083354000FLORASEAL, MODEL FS350DAdhezion Biomedical2009-07-20NZP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M495FS250D1PrimaryHIBCC0
M495FS250D0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical skin microbial sealantA sterile synthetic substance (e.g., cyanoacrylate) intended to be applied to the skin of a patient prior to surgical incision (typically over commonly used preoperative skin preparation and with or without standard surgical draping) to, upon polymerization, bond to the skin and fix microbes, reducing the risk of skin flora contamination during the surgical procedure. It is typically contained within a disposable, ready-to-use applicator. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume2.5Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit86 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
8287263791mwyer@adhezion.com

Regulatory Flags#

DUNS number
827716437
Device count
12
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
M495SP015V1SecurePortIVSP-015VSP-015V2018-01-30
M495SP015V2SecurePortIVSP-015VSP-015V2018-02-05
M495SP015V502SecurePortIVSP-015V50SP-015V502018-04-02
M495FS035T1FloraSeal MiniFS035TFS-035T2021-01-07
M495FS035T0FloraSeal MiniFS035TFS-035T2021-01-07
M495SS035T1SurgiSealSS-035TSS-035T2016-05-18
M495SS050S1SurgiSealSS-050SSS-050S2016-05-18
M495ST050S1SurgiSealST-050SST-050S2016-05-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05036912001595INTEGUSEALADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDNZP2024-11-26
05036912001625INTEGUSEALADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDNZP2024-11-26
M495FS035T1FloraSeal MiniADHEZION BIOMEDICAL, LLCNZP2021-01-07
M495FS035T0FloraSeal MiniADHEZION BIOMEDICAL, LLCNZP2021-01-07
00193494337360AVANOSAvanos Medical, Inc.NZP2020-07-16
00193494337377AVANOSAvanos Medical, Inc.NZP2020-07-16
20193494337364AVANOSAvanos Medical, Inc.NZP2020-07-16
10193494337374AVANOSAvanos Medical, Inc.NZP2020-07-16
M495SP015V502SecurePortIVADHEZION BIOMEDICAL, LLCNZP2018-04-02
M495SP015V2SecurePortIVADHEZION BIOMEDICAL, LLCNZP2018-02-05
M495SP015V1SecurePortIVADHEZION BIOMEDICAL, LLCNZP2018-01-30
10680651337365HalyardAvanos Medical, Inc.NZP2017-03-15
10680651337372HalyardAvanos Medical, Inc.NZP2017-03-15