FDA.reportPublic FDA data

SurgiMend®

Primary DI
10381780357346
Brand
SurgiMend®
Company
TEI BIOSCIENCES INC.
Model
606-206-003
Catalog number
606-206-003
Device description
SurgiMend® Macroporous 13 cm x 25 cm
Published
2017-05-26
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTMMesh, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162965000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162965000SurgiMend MP Collagen Matrix for Soft Tissue ReconstructionTei Biosciences, Inc.2017-02-16FTM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780357346PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178035734610381780357346

GMDN Terms#

Term, Definition table
TermDefinition
Extra-gynaecological surgical mesh, collagen, non-bioabsorbableA non-bioabsorbable, implantable material (e.g., flat sheet) made from animal-derived collagen intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. It is constructed of cross-linked collagen (e.g., with glutaraldehyde). Disposable devices associated with implantation may be supplied with the mesh.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from excessive heat and direct sunlight.
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
No natural rubber latex
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
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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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