FDA.reportPublic FDA data

MiroFlex®

Primary DI
00857072005354
Brand
MiroFlex®
Company
REPRISE BIOMEDICAL, INC.
Model
BLM-100-01-0608
Device description
Biologic Matrix
Published
2023-05-10
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
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857072005354PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857072005354008570720053548570720053540857072005354

GMDN Terms#

Term, Definition table
TermDefinition
Extra-gynaecological surgical mesh, collagen, bioabsorbableA 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) and may also be intended as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation may be supplied with the mesh.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height8Centimeter
Width6Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
952-377-8238customerservice@reprisebio.com

Regulatory Flags#

DUNS number
043611421
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857072005118MiroDerm FenestratedBLM-200-02-03072020-09-30
00857072005620Miro3D®30062025-09-30
00857072005637Miro3D®30092025-09-30
00857072005644Miro3D®30112025-09-30
00857072005651Miro3D®30132025-09-30
00857072005668MiroDry™ 60062025-09-30
00857072005675MiroDry™ 60142025-09-30
00857072005682MiroDry™ 60212025-09-30
00857072005699MiroDry™ 60232025-09-30
00857072005576MiroDry™ 60222025-01-17
00857072005552Miro3D®30072024-07-22
00857072005569Miro3D®30122024-07-22
00857072005491MiroDry™ 60002024-03-28
00857072005507MiroDry™ 60052024-03-28
00857072005514MiroDry™ 60102024-03-28
00857072005521MiroDry™ 60152024-03-28
00857072005538MiroDry™ 60202024-03-28
00857072005545MiroDry™ 60252024-03-28
00857072005453MiroTract Wound Matrix50002023-12-21
00857072005460MiroTract Wound Matrix50202023-12-21

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Primary DI, Brand, Company table
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00802526630019EluPro™Boston Scientific CorporationFTM2026-05-27
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