FDA.reportPublic FDA data

INTEGUSEAL

Primary DI
05036912001625
Brand
INTEGUSEAL
Company
ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITED
Model
33737
Device description
IS200
Published
2024-11-26
Public version status
New
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
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
05036912001632PackageGS110In Commercial Distribution
05036912001649PackageGS12In Commercial Distribution
05036912001625PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05036912001632050369120016325036912001632
05036912001649050369120016495036912001649
05036912001625050369120016255036912001625

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+448444125754enquiries@admedsol.com

Regulatory Flags#

DUNS number
236059171
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05036912001595INTEGUSEAL337362024-11-26
05036912001410LIQUIFIX FIX8720140322023-06-23
05036912001441LIQUIFIX Precision Open720140332023-06-23
05036912001427LIQUIFIX FIX8720140322023-06-23
05036912001458LIQUIFIX Precision Open720140332023-06-23
05036912000758LiquiBand ButylLQB0012023-06-12
05036912001687LiquiBand ExceedLBE0012023-06-12
05036912001717LiquiBand Exceed XSLBEXS0012023-06-12
05036912001748LiquiBand Octyl MiniLBCM0012023-06-12
05036912000406LiquiBand ButylLQB0012023-06-12
05036912001694LiquiBand ExceedLBE0012023-06-12
05036912001724LiquiBand Exceed XSLBEXS0012023-06-12
05036912001755LiquiBand Octyl MiniLBCM0012023-06-12
05036912001502LiquiBand SecureM13222023-05-19
05036912001533LiquiBand SecureM13422023-05-19
05036912001557LiquiBand SecureM13662023-05-19
05036912001519LiquiBand SecureM13222023-05-19
05036912001540LiquiBand SecureM13422023-05-19
05036912001571LiquiBand SecureM13662023-05-19
05036912001656LiquiBand XL72014046A2023-03-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05036912001595INTEGUSEALADVANCED 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
M495FS250D1FloraSealADHEZION BIOMEDICAL, LLCNZP2016-11-21