FDA.reportPublic FDA data

Cardion™

Primary DI
00386190002087
Brand
Cardion™
Company
ACELL, INC.
Model
PP1015
Catalog number
PP1015
Device description
Cardion™ for Pericardial Repair 10 X 15 cm
Published
2020-07-31
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
PSQIntracardiac patch or pledget, biologically derived

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PSQIntracardiac Patch Or Pledget, Biologically DerivedCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191734000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191734000MatriStem UBM Pericardial PatchAcell, Inc.2019-11-22PSQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00386190002087PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00386190002087003861900020873861900020870386190002087

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
Length15Centimeter
Width10Centimeter

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
Primary DIBrandModelCatalogPublished
10381780486893MEDIHONEY®31840318402019-03-07
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00877234001635PhotoFix Decellularized Bovine PericardiumArtivion, Inc.PSQ2026-05-29
00877234001642PhotoFix Decellularized Bovine PericardiumArtivion, Inc.PSQ2026-05-29
00877234001659PhotoFix Decellularized Bovine PericardiumArtivion, Inc.PSQ2026-05-29
00877234001666PhotoFix Decellularized Bovine PericardiumArtivion, Inc.PSQ2026-05-29
00877234001673PhotoFix Decellularized Bovine PericardiumArtivion, Inc.PSQ2026-05-29
00877234001680PhotoFix Decellularized Bovine PericardiumArtivion, Inc.PSQ2026-05-29
00877234001697PhotoFix Decellularized Bovine PericardiumArtivion, Inc.PSQ2026-05-29
00877234001703PhotoFix Decellularized Bovine PericardiumArtivion, Inc.PSQ2026-05-29
00850023375087CardiaMendHelios Cardio Inc.PSQ2023-07-07
00085412818313Supple Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2023-05-15
00085412818375Supple Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2023-05-15
00085412818405Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2023-05-15
00085412818429Supple Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2023-05-15
00085412818443Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2023-05-15
00085412818597Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2023-05-15
00085412818610Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2023-05-15
00085412818658Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2023-05-15
00085412818672Supple Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2023-05-15
00085412818696Supple Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2023-05-15
00850023375063CardiaMendHelios Cardio Inc.PSQ2022-12-13
00850023375070CardiaMendHelios Cardio Inc.PSQ2022-12-13
00085412818474Vascu-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2022-11-28
00085412818498Vascu-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2022-11-28
00085412818511Vascu-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2022-11-28
00085412818535Vascu-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2022-11-28
00085412818559Vascu-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2022-11-28
00085412818573Vascu-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2022-11-28
00085412818634Vascu-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2022-11-28
00850023375001CardiaMendHelios Cardio Inc.PSQ2022-02-01
00850023375018CardiaMendHelios Cardio Inc.PSQ2022-02-01