FDA.reportPublic FDA data

Rotation Medical Reconstituted Collagen Scaffold - Mini-Open, Medium

Primary DI
00854501006029
Brand
Rotation Medical Reconstituted Collagen Scaffold - Mini-Open, Medium
Company
Smith & Nephew, Inc.
Model
2999-2
Published
2015-10-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FTMMesh, Surgical
OWYMesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTMMesh, SurgicalGeneral, Plastic Surgery2
OWYMesh, Surgical, Collagen, Orthopaedics, Reinforcement Of TendonGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854501006029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854501006029008545010060298545010060290854501006029

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
045483575
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556832448Salto Talaris Total Ankle ProsthesisMJU048TMJU048T2023-02-02
00885556165560NA76515310765153102026-07-16
00885556923023NA76547001765470012026-07-16
00885556925089NA74034445740344452026-07-14
00885556925379CORIOGRAPHROB20032ROB200322026-07-08
00885556925386CORIOGRAPHROB20031ROB200312026-07-08
00885556904879EVOS70887105708871052026-06-25
00885556904923EVOS70897130708971302026-06-25
00885556906163EVOS70879090708790902026-06-25
00885556906170EVOS70879095708790952026-06-25
00885556906187EVOS70879100708791002026-06-25
00885556906194EVOS70879105708791052026-06-25
00885556906200EVOS70879110708791102026-06-25
00885556906217EVOS70879115708791152026-06-25
00885556906224EVOS70879120708791202026-06-25
00885556906231EVOS70879125708791252026-06-25
00885556906248EVOS70879130708791302026-06-25
00885556906255EVOS70879135708791352026-06-25
00885556906262EVOS70879140708791402026-06-25
00885556906279EVOS70879145708791452026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00802526629907CanGaroo®Boston Scientific CorporationFTM2026-05-27
00802526629914CanGaroo®Boston Scientific CorporationFTM2026-05-27
00802526629921CanGaroo®Boston Scientific CorporationFTM2026-05-27
00802526629938CanGaroo®Boston Scientific CorporationFTM2026-05-27
00802526629945CanGaroo®Boston Scientific CorporationFTM2026-05-27
00802526630002EluPro™Boston Scientific CorporationFTM2026-05-27
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
09421907331881OviTex® CoreAROA BIOSURGERY LIMITEDFTM2025-11-26
09421907331935OviTex® 1SAROA BIOSURGERY LIMITEDFTM2025-11-26
09421907331942OviTex® 1SAROA BIOSURGERY LIMITEDFTM2025-11-26
09421907331959OviTex® 1SAROA BIOSURGERY LIMITEDFTM2025-11-26
09421907331973OviTex® 1SAROA BIOSURGERY LIMITEDFTM2025-11-26
09421908222065OviTex® 2SAROA BIOSURGERY LIMITEDFTM2025-11-26
09421908222096OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTM2025-11-26
09421908222102OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTM2025-11-26
09421908222157OviTex® InguinalAROA BIOSURGERY LIMITEDFTM2025-11-26
00085412658681Peri-Strips Dry with VeritasSYNOVIS LIFE TECHNOLOGIES, INC.FTM2024-11-21
10653405990123BioBraceConmed CorporationOWY2024-09-20
10653405990130BioBraceConmed CorporationOWY2024-09-20
10653405990147BioBraceConmed CorporationOWY2024-09-20
10653405990154BioBraceConmed CorporationOWY2024-09-20
B454VSC10VersaWrapAlafair Biosciences, Inc.FTM2024-06-10
09421906661903OviTex® IHRAROA BIOSURGERY LIMITEDFTM2024-03-21
09421906661910OviTex® IHRAROA BIOSURGERY LIMITEDFTM2024-03-21
09421906661927OviTex® IHRAROA BIOSURGERY LIMITEDFTM2024-03-21
10653405988946BioBraceConmed CorporationOWY2024-02-12