FDA.reportPublic FDA data

ActivBraid

Primary DI
00810063820633
Brand
ActivBraid
Company
Embody, Inc.
Model
AB-150T-0W
Device description
ActivBraid 1.5mm Collagen-UHMWPE Co-Braid Suture Tape, White/Black, 36” (91.5cm)
Published
2025-10-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GATSuture, Nonabsorbable, Synthetic, Polyethylene

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GATSuture, Nonabsorbable, Synthetic, PolyethyleneGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223822000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223822000ACTIVBRAID™Embody, Inc.2023-06-02GAT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810063820630PackageGS112In Commercial Distribution
00810063820633PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081006382063010810063820630
00810063820633008100638206338100638206330810063820633

GMDN Terms#

Term, Definition table
TermDefinition
Collagen-polymer sutureA multiple-strand (multifilament) thread made from strands of both a natural, bioabsorbable collagen derived from animals (e.g., sheep or bovine intestines) and non-bioabsorbable polymer [e.g., polyethylene (PE)], intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues (includes use in orthopaedic surgeries). It may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. It provides temporary wound support until the wound sufficiently heals to withstand normal stress. This is a single-use device.

Regulatory Flags#

DUNS number
079544913
Device count
1
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
10705031097889ETHIBOND EXCELETHICON, LLCGAT2026-07-17
10705031102996ETHIBOND EXCELETHICON, LLCGAT2026-07-17
10705031103085ETHIBOND EXCELETHICON, LLCGAT2026-07-17
10705031238404ETHIBOND EXCELETHICON, LLCGAT2026-07-17
10705031461963ETHIBOND EXCELETHICON, LLCGAT2026-07-17
10705031461970ETHIBOND EXCELETHICON, LLCGAT2026-07-17
07649990202419Drill S-PI-A1.6 extra shortSurgical Fusion Technologies GmbHGAT2026-01-18
00888867525924Arthrex®ARTHREX, INC.GAT2025-10-20
00888867525931Arthrex®ARTHREX, INC.GAT2025-10-20
07649990202174Geomax Reamer S-PI-A1.6Surgical Fusion Technologies GmbHGAT2025-10-01
07649990202211Geomax Reamer S-PI-A2.3Surgical Fusion Technologies GmbHGAT2025-10-01
07649990202372Geomax Reamer S-PI-A3.0Surgical Fusion Technologies GmbHGAT2025-10-01
07649990202389Handle SSurgical Fusion Technologies GmbHGAT2025-10-01
07649990202396Geomax Reamer SetSurgical Fusion Technologies GmbHGAT2025-10-01
07649990202228SF Push-in Anchor 1.6Surgical Fusion Technologies GmbHGAT2024-04-12
07649990202303Sonotrode S-PISurgical Fusion Technologies GmbHGAT2024-04-12
07649990202204SupraFuser B GeneratorSurgical Fusion Technologies GmbHGAT2024-02-06
07649990202020Tray_SF Push-In Anchor 2.3Surgical Fusion Technologies GmbHGAT2024-01-10
07649990202181Handpiece Front CoverSurgical Fusion Technologies GmbHGAT2024-01-10
07649990202013Tray_SF Push-in Anchor 2.3Surgical Fusion Technologies GmbHGAT2023-12-14
07649990202037Sonotrode PI-S 2.3Surgical Fusion Technologies GmbHGAT2023-12-14
07649990202044Twist Drill PI-C 1.8Surgical Fusion Technologies GmbHGAT2023-12-14
07649990202051Wrench 5.0Surgical Fusion Technologies GmbHGAT2023-12-14
07649990202150BoneWelder 150-W1Surgical Fusion Technologies GmbHGAT2023-12-14
07649990202167SF Push-in Anchor 2.3Surgical Fusion Technologies GmbHGAT2023-12-08
00860007711206EasyWhipWinter Innovations Inc.GAT2021-11-18
10884521758803VascufilCovidien LPGAT2020-07-19
10652927144151DemeBONDDemetech CorporationGAT2019-07-16
10652927144168DemeBONDDemetech CorporationGAT2019-07-16
10652927150312DemeBONDDemetech CorporationGAT2019-07-16