FDA.reportPublic FDA data

RevizeTM-X

Primary DI
10381780357315
Brand
RevizeTM-X
Company
TEI BIOSCIENCES INC.
Model
611-005-002
Catalog number
611-005-002
Device description
Revize™-X Collagen Matrix for Soft Tissue Reconstruction
Published
2017-10-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTMMesh, surgical
OXHMesh, surgical, collagen, plastic and reconstructive surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTMMesh, SurgicalGeneral, Plastic Surgery2
OXHMesh, Surgical, Collagen, Plastic And Reconstructive SurgeryGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171357000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171357000SurgiMend PRS Meshed, Revize-XIntegra Lifesciences Corporation (Owner of Tei Biosciences)2017-06-07OXH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780357315PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178035731510381780357315

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose surgical mesh, biologic-polymer compositeA flat or three-dimensional (3-D) implantable material comprised of both a bioabsorbable animal-derived biologic (e.g., porcine collagen) and a non-bioabsorbable synthetic polymer (e.g., polypropylene) intended for multiple defective tissue repair applications at different anatomical zones (e.g., breast, cardiac, abdominal) that includes an extra-abdominal application(s) [e.g., cardiac, plastic surgery, breast reconstruction]. It may also be used as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do no use if package is damaged
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
796253292
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780540762Durepair™62106621062025-01-31
10381780540823Durepair™62110621102025-01-31
10381780540786Durepair™62158621582025-01-31
10381780540854Durepair™62100621002025-01-31
10381780540878Durepair™62111621112025-01-31
10381780540892Durepair™62105621052025-01-31
10381780113317PriMatrix®607-001-125607-001-1252015-10-21
10381780113294PriMatrix®607-001-009607-001-0092015-10-21
10381780113300PriMatrix®607-001-112607-001-1122015-10-21
10381780113324PriMatrix®607-001-225607-001-2252015-10-21
10381780113331PriMatrix®607-001-440607-001-4402015-10-21
10381780113348PriMatrix®607-001-660607-001-6602015-10-21
10381780113355PriMatrix®607-001-812607-001-8122015-10-21
10381780113362PriMatrix®607-001-880607-001-8802015-10-21
10381780113379PriMatrix®607-004-440607-004-4402015-10-21
10381780113386PriMatrix®607-004-660607-004-6602015-10-21
10381780113393PriMatrix®607-004-880607-004-8802015-10-21
10381780113409PriMatrix®607-005-125607-005-1252015-10-23
10381780113416PriMatrix®607-005-220607-005-2202015-10-21
10381780113423PriMatrix®607-005-225607-005-2252015-10-21

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