FDA.reportPublic FDA data

AVANOS

Primary DI
10193494337374
Brand
AVANOS
Company
Avanos Medical, Inc.
Model
33737
Catalog number
33737
Device description
INTEGUSEAL Microbial Sealant
Published
2020-07-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
false

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
K052870000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052870000INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200Kimberly-Clark Corp.2006-09-29NZP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10193494337374PackageGS110In Commercial Distribution
20193494337371PackageGS12In Commercial Distribution
00193494337377PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1019349433737410193494337374
2019349433737120193494337371
00193494337377001934943373771934943373770193494337377

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
Area/Surface Area1250Square centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(844)428-2667PIQ@AVANOS.COM

Regulatory Flags#

DUNS number
079375431
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
00812120004895Game Ready* System120008544550500-042026-07-31
00812120005076Game Ready* Full Leg Boot Wrap, Medium120008563590923-042026-07-31
00812120005113Game Ready* Ankle Wrap, Large120008549590330-042026-07-31
00812120005120Game Ready* Ankle Wrap, Extra Large120008550590340-042026-07-31
00812120005137Game Ready* Shoulder Wrap, Medium, Right120008551590422-042026-07-31
00812120005144Game Ready* Shoulder Wrap, Medium, Left120008552590424-042026-07-31
00812120005151Game Ready* Shoulder Wrap, Large, Right120008553590432-042026-07-31
00812120005168Game Ready* Shoulder Wrap, Large, Left120008554590434-042026-07-31
00812120005175Game Ready* Back Wrap120008555590500-042026-07-31
00812120005182Game Ready* C-T Spine Wrap, Large120008556590502-042026-07-31
00812120005199Game Ready* Hip/Groin Wrap, Right120008557590602-042026-07-31
00812120005205Game Ready* Hip/Groin Wrap, Left120008558590604-042026-07-31
00812120005212Game Ready* Hand/Wrist Wrap120008559590811-042026-07-31
00812120005229Game Ready* Flexed Elbow Wrap120008560590903-042026-07-31
00812120005236Game Ready* Half Leg Boot Wrap120008561590906-042026-07-31
00812120005243Game Ready* Full Leg Boot Wrap, Large120008562590922-042026-07-31
00812120005250Game Ready* Straight Knee Sleeve120009290510100-042026-07-31
00812120005267Game Ready* Articulated Knee Sleeve120009291510160-042026-07-31
00812120005274Game Ready* Straight Elbow Sleeve120009292510200-042026-07-31
00812120005281Game Ready* Ankle Sleeve, Large120009293510330-042026-07-31

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
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
M495FS250D1FloraSealADHEZION BIOMEDICAL, LLCNZP2016-11-21