FDA.reportPublic FDA data

Restella

Primary DI
09421904065956
Brand
Restella
Company
AROA BIOSURGERY LIMITED
Model
R20143-0820P
Device description
Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.
Published
2019-04-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTLMesh, Surgical, Polymeric
FTMMesh, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTLMesh, Surgical, PolymericGeneral, Plastic Surgery2
FTMMesh, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09421904065956PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09421904065956094219040659569421904065956

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose surgical mesh, biologic-polymer compositeA sterile, flat or three-dimensional (3-D) implantable material comprised of both a bioabsorbable animal-derived biologic (e.g., porcine collagen) and a non-bioabsorbable synthetic polymer (e.g., polypropylene) intended for multiple defective tissue repair applications at different anatomical zones (e.g., breast, cardiac, abdominal) that includes an extra-abdominal application(s) [e.g., cardiac, 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature25 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8448352246customerservice@telabio.com

Regulatory Flags#

DUNS number
594540572
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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09421906661910OviTex® IHRF10243-1317I2024-03-21
09421906017625Myriad Matrix™ Soft Tissue BioscaffoldSR05LG0505US2021-08-12
09421906017236Endoform™ Natural Restorative Bioscaffold5293162021-08-20
09421906017243Endoform™ Natural Restorative Bioscaffold5293152021-08-20
09421906017250Endoform™ Natural Restorative Bioscaffold5293142021-08-20
09421906017267Endoform™ Natural Restorative Bioscaffold5293132021-08-20
09421906017281Endoform™ Natural Restorative Bioscaffold5293112021-08-20
09421906017304Endoform™ Natural Restorative Bioscaffold5293022021-08-20
09421906017434Endoform™ Antimicrobial Restorative Bioscaffold6293042021-08-20
09421906017465Endoform™ Antimicrobial Restorative Bioscaffold6293152021-08-20
09421906017472Endoform™ Antimicrobial Restorative Bioscaffold6293142021-08-20
09421906017489Endoform™ Antimicrobial Restorative Bioscaffold6293132021-08-20
09421906017496Endoform™ Antimicrobial Restorative Bioscaffold6293122021-08-20
09421906017502Endoform™ Antimicrobial Restorative Bioscaffold6293112021-08-20
09421906661903OviTex® IHRF10244-1017I2024-03-21
09421906661927OviTex® IHRF10243-1017I2024-03-21
09421906661552OviTex® LPRF10244-1525L2023-06-15
09421906661569OviTex® LPRF10244-1520L2023-06-15
09421906017670Myriad Matrix™ Soft Tissue BioscaffoldSR02LG1010US2022-04-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00802526630019EluPro™Boston Scientific CorporationFTM2026-05-27
09421908222393Myriad Matrix™ Restore Restorative BioscaffoldAROA BIOSURGERY LIMITEDFTM2026-01-30
09421908222416Myriad Matrix™ Restore Restorative BioscaffoldAROA BIOSURGERY LIMITEDFTM2026-01-30
09421908222430Myriad Matrix™ Restore Restorative BioscaffoldAROA BIOSURGERY LIMITEDFTM2026-01-30
09421908222454Myriad Matrix™ Restore Restorative BioscaffoldAROA BIOSURGERY LIMITEDFTM2026-01-30
09421907331874OviTex® CoreAROA BIOSURGERY LIMITEDFTL2025-11-26
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09421907331942OviTex® 1SAROA BIOSURGERY LIMITEDFTM2025-11-26
09421907331959OviTex® 1SAROA BIOSURGERY LIMITEDFTM2025-11-26
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09421907331997OviTex® 1SAROA BIOSURGERY LIMITEDFTL2025-11-26
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09421908222102OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTM2025-11-26
09421908222119OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTL2025-11-26
09421908222126OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTL2025-11-26
09421908222140OviTex® InguinalAROA BIOSURGERY LIMITEDFTL2025-11-26
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