FDA.reportPublic FDA data

TAPESTRY RC Biointegrative Implant System

Primary DI
00810063820510
Brand
TAPESTRY RC Biointegrative Implant System
Company
Embody, Inc.
Model
TR-2626-B6
Catalog number
TR-2626-B6
Device description
Convenience Kit
Published
2024-02-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GEACannula, Surgical, General & Plastic Surgery
MAIFastener, Fixation, Biodegradable, Soft Tissue
OWYMesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEACannula, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1
MAIFastener, Fixation, Biodegradable, Soft TissueOrthopedic2
OWYMesh, Surgical, Collagen, Orthopaedics, Reinforcement Of TendonGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810063820510PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810063820510008100638205108100638205100810063820510

GMDN Terms#

Term, Definition table
TermDefinition
Arthroscopic surgical procedure kit, non-medicated, single-useA collection of various sterile surgical and endoscopic instruments, dressings, and additional materials intended to be used specifically to perform an arthroscopic surgical procedure. It does not contain any pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079544913
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810063820459TAPESTRY Biointegrative Implant with IntroducerTR-2626-21TR-2626-212023-09-21
00810063820466TAPESTRY Biointegrative Implant with IntroducerTR-2626-31TR-2626-312023-09-21
00810063820039Tapestry Biointegrative ImplantTP-2030-012023-05-11
00810063820077Tapestry Biointegrative ImplantTS-4030-022023-05-11
00810063820169Embody CannulaEM-A001-01EM-A001-012022-06-02
00810063820176Embody CannulaEM-A002-01EM-A002-012022-06-02
00810063820183Embody CannulaEM-A003-01EM-A003-012022-06-02
00810063820107TAPESTRY Biointegrative Implant with IntroducerTR-3030-21TR-3030-212022-06-01
00810063820138TAPESTRY Biointegrative Implant with IntroducerTR-3030-31TR-3030-312022-06-01
00810063820060TAPESTRY Biointegrative ImplantTS-5040-022021-04-01
00810063820008TAPESTRY BIointegrative Implant with Insertion SleeveTP-7050-022020-11-20
00810063820015TAPESTRY Biointegrative ImplantTP-7025-022020-11-20
00810063820022TAPESTRY Biointegrative ImplantTP-2550-01TP-2550-012020-11-20
00810063820046TAPESTRY Biointegrative ImplantTP-3030-012020-11-20
00810063820053TAPESTRY Biointegrative ImplantTP-4030-012020-11-20
00810063820381ACTIVBRAIDAB-021R-1BAB-021R-1B2023-08-31
00810063820398ACTIVBRAIDAB-250T-0WAB-250T-0W2023-08-31
00810063820404ACTIVBRAIDAB-200R-1WAB-200R-1W2023-08-31
00810063820411ACTIVBRAIDAB-200R-1BAB-200R-1B2023-08-31
00810063820428ACTIVBRAIDAB-150T-1WAB-150T-1W2023-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816537023012FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00816537023029FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00816537023036FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00816537023043FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00816537023050FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00816537023067FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00816537023234FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00840329838232BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GEA2026-06-08
00840329838249BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GEA2026-06-08
G4533312250PEAK MEDICALPeak Medical Distribution Inc.GEA2026-06-08
00810130456420Medco ManufacturingMedco Manufacturing LLCGEA2026-06-05
00810130456437Medco ManufacturingMedco Manufacturing LLCGEA2026-06-05
00810130456444Medco ManufacturingMedco Manufacturing LLCGEA2026-06-05
00810130456451Medco ManufacturingMedco Manufacturing LLCGEA2026-06-05
00810130456468Medco ManufacturingMedco Manufacturing LLCGEA2026-06-05
00810130456475Medco ManufacturingMedco Manufacturing LLCGEA2026-06-05
00810130456482Medco ManufacturingMedco Manufacturing LLCGEA2026-06-05
00810130456505Medco ManufacturingMedco Manufacturing LLCGEA2026-06-05
00810130456413Medco ManufacturingMedco Manufacturing LLCGEA2026-06-02
00846338005436Working PortELLIQUENCE, LLCGEA2026-06-02
00846338007324Working PortELLIQUENCE, LLCGEA2026-06-02
00846338007331Working PortELLIQUENCE, LLCGEA2026-06-02
00846338007348Working PortELLIQUENCE, LLCGEA2026-06-02
00846338007355Working PortELLIQUENCE, LLCGEA2026-06-02
00846338007362Working PortELLIQUENCE, LLCGEA2026-06-02
00846338005535Suction TubeELLIQUENCE, LLCGEA2026-06-01
00846338005542Suction TubeELLIQUENCE, LLCGEA2026-06-01
00810130456390Medco ManufacturingMedco Manufacturing LLCGEA2026-05-29
G453332414200PEAK MEDICALPeak Medical Distribution Inc.GEA2026-05-08
00840329837365BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GEA2026-05-04