FDA.reportPublic FDA data

Gentrix®

Primary DI
00386190001554
Brand
Gentrix®
Company
ACELL, INC.
Model
PSMT2025
Catalog number
PSMT2025
Device description
Gentrix® Surgical Matrix Thick 20 x 25 cm
Published
2017-06-30
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
OXKMesh, surgical, collagen, large abdominal wall defects

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTMMesh, SurgicalGeneral, Plastic Surgery2
OXHMesh, Surgical, Collagen, Plastic And Reconstructive SurgeryGeneral, Plastic Surgery2
OXKMesh, Surgical, Collagen, Large Abdominal Wall DefectsGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K041140000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041140000ACELL UBM SURGICAL MESH ML AND MLPLUSAcell, Inc.2004-07-07FTM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00386190001554PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00386190001554003861900015543861900015540386190001554

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose surgical mesh, collagen, bioabsorbableA sterile, bioabsorbable, flat or three-dimensional (3-D) implantable material made from animal-derived collagen intended for multiple tissue defect repair/hernia reduction (e.g., inguinal, ventral/incisional, umbilical, femoral) applications including an extra-abdominal application(s) [e.g., 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
Length25Centimeter
Width20Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a clean, dry environment at room temperature

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)826-2926customerservice@acell.com

Regulatory Flags#

DUNS number
137258252
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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10381780486824MediHoney®31515315152018-08-30
10381780486831MediHoney®31535315352018-08-28
10381780486886MediHoney®31815318152018-08-30
10381780486930MediHoney®31505315052019-03-06
10381780486978MediHoney®31805318052018-09-14
00386190002056MicroMatrix®MMFX05MMFX052023-10-02
00386190001820Cytal®WSR1625WSR16252019-12-16
00386190001837Cytal®WSR1635WSR16352019-12-16
00386190000007MatriStemMM0020MM00202017-01-10
00386190000014MatriStemMM0030MM00302017-01-10
00386190000052MatriStemWS0303WS03032017-01-10
00386190000076MatriStemWS0307WS03072017-01-10
00386190000090MatriStemWS0710WS07102017-01-10
00386190000113MatriStemWS1015WS10152017-01-10
00386190000137MatriStemMM0060MM00602017-01-10
00386190000151MatriStemMM0100MM01002017-01-10
00386190000168MatriStemMM0100FMM0100F2017-01-10
00386190000182MicroMatrix®MM0200MM02002017-01-10
00386190000199MatriStemMM0200FMM0200F2017-01-10

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