TissuGlu Surgical Adhesive

Primary DI
M690TG100US0
Brand
TissuGlu Surgical Adhesive
Company
COHERA MEDICAL, INC.
Model
TG100US
Catalog number
TG100US
Device description
TissuGlu Surgical Adhesive
Published
2017-02-13
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
PJKTissue Adhesive For Internal Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PJKTissue Adhesive For Internal UseGeneral, Plastic Surgery3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P130023000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P130023000COHERA MEDICAL TISSUGLUCohera Medical, Inc.2015-02-03PJK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M690TG100US3PackageHIBCC3In Commercial Distribution
M690TG100US0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical internal adhesive/sealant, synthetic polymerA biodegradable synthetic polymer material [e.g., cyanoacrylate, poly glycerol sebacate arylate (PGSA)] intended to be used for internal surgical applications to bond a wide range of tissue types (e.g., bowel, liver, lung, vascular, urological) and might in addition be intended to achieve haemostasis through tissue sealing. It is applied using a disposable applicator (which may be included), and is intended to be fast-setting (self- or light-induced) to form a thin elastic film. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at Room Temperature 25C
Storage Environment Temperature0 Degrees Celsius45 Degrees Celsius

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
(800) 641-7458cs@coheramed.com

Regulatory Flags#

DUNS number
145195199
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true