FDA.reportPublic FDA data

SurgiPure® XD

Primary DI
05060260020038
Brand
SurgiPure® XD
Company
Tissue Regenix Wound Care Inc.
Model
101015XD
Catalog number
101015XD
Device description
Reconstructive Tissue Matrix
Published
2016-09-01
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
FTMMesh, Surgical

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152206000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152206000SurgiPure XD Reconstructive Tissue MatrixTissue Regenix Group Plc2016-03-08FTM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060260020038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060260020038050602600200385060260020038

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
Depth1.5Centimeter
Length10Centimeter
Width10Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-855-452-0133orderus@tissueregenix.com

Regulatory Flags#

DUNS number
031826073
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
05060260020014SurgiPure® XD020515XD020515XD2016-09-01
05060260020021SurgiPure® XD050515XD050515XD2016-09-01
05060260020045SurgiPure® XD102015XD102015XD2016-09-01
05060260020052SurgiPure® XD152015XD152015XD2016-09-01
05060260020069SurgiPure® XD152515XD152515XD2016-09-01
05060260020076SurgiPure® XD202015XD202015XD2016-09-01
05060260020083SurgiPure® XD203015XD203015XD2016-09-01
05060260020090SurgiPure® XD204015XD204015XD2016-09-01
05060260020106SurgiPure® XD254015XD254015XD2016-09-01
05060260020113SurgiPure® XD101515XD101515XD2016-09-01
05060260020120SurgiPure® XD071015XD071015XD2016-09-01

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Primary DI, Brand, Company table
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