FDA.reportPublic FDA data

Halyard

Primary DI
10680651337372
Brand
Halyard
Company
Avanos Medical, Inc.
Model
33737
Catalog number
33737-01
Device description
HALYARD* INTEGUSEAL* Microbial Sealant IS 200
Published
2017-03-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20680651337379PackageGS110In Commercial Distribution
30680651337376PackageGS12In Commercial Distribution
10680651337372PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2068065133737920680651337379
3068065133737630680651337376
1068065133737210680651337372

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.

Contacts#

Phone, Email table
PhoneEmail
+1(844)425-9273xxx@xxx.xxx

Regulatory Flags#

DUNS number
079375431
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10680651458350Halyard4583525-0082017-09-18
10680651458367Halyard4583625-0102017-09-18
10680651458374Halyard4583725-0122017-09-18
10680651469035Halyard4690325-0142017-09-18
10680651469042Halyard4690425-0162017-09-18
10680651469059Halyard4690525-0182017-09-18
00193494135263AVANOS*500108750010872020-09-25
10680651124767COOLIEF* Cooled Radiofrequency QUICKCLAMP* Device12476SIA-QC2016-05-17
00812120005083Game Ready* 6' Dual Connector Hose, Rental120004997570302-RN2026-04-24
00812120005090Game Ready* 6' Medical Connector Hose, Rental120004999570304-RN2026-04-24
00812120005106Game Ready* Wrap Extender Strap Kit, Rental120004998573226-RN2026-04-17
00609038351117AVANOS35111351112020-04-01
00609038351124AVANOS35112351122020-04-01
00609038351131AVANOS35113351132020-04-01
00609038351148AVANOS35114351142020-04-01
00609038351155AVANOS35115351152020-04-01
00609038351162AVANOS35116351162020-04-01
00609038351179AVANOS35117351172020-04-01
00609038351186AVANOS35118351182020-04-01
00609038351193AVANOS35119351192020-04-01

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
M495FS250D1FloraSealADHEZION BIOMEDICAL, LLCNZP2016-11-21