FDA.reportPublic FDA data

Rotation Medical Reconstituted Collagen Scaffold - Mini-Open, Large

Primary DI
00854501006036
Brand
Rotation Medical Reconstituted Collagen Scaffold - Mini-Open, Large
Company
Smith & Nephew, Inc.
Model
2999-3
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
00854501006036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854501006036008545010060368545010060360854501006036

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
00885556925171REAL INTELLIGENCEROB100021FROB100021F2026-07-30
00885556925188REAL INTELLIGENCEROB100022FROB100022F2026-07-30
00885556925195REAL INTELLIGENCEROB10024FROB10024F2026-07-30
00885556925201REAL INTELLIGENCEROB10025FROB10025F2026-07-30
00885556925218REAL INTELLIGENCEROB10027FROB10027F2026-07-30
00885556925225REAL INTELLIGENCEROB10003FROB10003F2026-07-30
00885556925232REAL INTELLIGENCEROB10013FROB10013F2026-07-30
00885556925249REAL INTELLIGENCEROB10015FROB10015F2026-07-30
00885556757277REAL INTELLIGENCEROB10010ROB100102020-07-02
00885556757307REAL INTELLIGENCEROB10011ROB100112020-07-02
00885556757314REAL INTELLIGENCEROB10012ROB100122020-07-02
00885556909393NA52856B52856B2025-09-24
00885556909317NA52858-0152858-012025-05-08
00885556909331NA52858-0252858-022025-05-08
00885556909348NA55085550852025-05-08
00885556909362NA52781-1052781-102025-05-08
00885556909386NA52876B52876B2025-05-08
00885556909423NA52855-4052855-402025-05-08
00885556909430NA52855-6552855-652025-05-08
00885556909447NA52781A52781A2025-05-08

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00802526629938CanGaroo®Boston Scientific CorporationFTM2026-05-27
00802526629945CanGaroo®Boston Scientific CorporationFTM2026-05-27
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00802526630019EluPro™Boston Scientific CorporationFTM2026-05-27
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09421907331959OviTex® 1SAROA BIOSURGERY LIMITEDFTM2025-11-26
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09421908222096OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTM2025-11-26
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10653405990130BioBraceConmed CorporationOWY2024-09-20
10653405990147BioBraceConmed CorporationOWY2024-09-20
10653405990154BioBraceConmed CorporationOWY2024-09-20
00859389005331EluPro Antibiotic-Eluting BioEnvelopeElutia Med LLCFTM2024-09-06
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B454VSC10VersaWrapAlafair Biosciences, Inc.FTM2024-06-10
09421906661903OviTex® IHRAROA BIOSURGERY LIMITEDFTM2024-03-21
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