FDA.reportPublic FDA data

HyperSuture

Primary DI
00810129094480
Brand
HyperSuture
Company
Threadstone LLC
Model
TST-178N
Catalog number
TST-178N
Device description
"1.5mm White/Blue UHMWPE Surgical Suture Tape, 36"" w/ 26mm Taper Needle"
Published
2026-04-07
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810129094480PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810129094480008101290944808101290944800810129094480

GMDN Terms#

Term, Definition table
TermDefinition
Polyolefin/fluoropolymer suture, multifilamentA multiple-strand (multifilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polypropylene, polyethylene) or fluoropolymer (e.g., polytetrafluoroethylene, polyvinylidene fluoride) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.

Regulatory Flags#

DUNS number
104319989
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810129094442HyperSutureTSS-253CTSS-253C2026-04-13
00810129094459HyperSutureTSS-522CNLTSS-522CNL2026-04-13
00810129094466HyperSutureTST-1501TST-15012026-04-13
00810129094473HyperSutureTST-288NLTST-288NL2026-04-13
00810129094497Aztron Suture TapeST-04-PST-04-P2026-04-09
00810129094435HyperSutureTST-1532NLTST-1532NL2026-04-07
00810129093193HyperSutureTST-156LTST-156L2026-01-09
00810129092363HyperSutureTSS-504CNLTSS-504CNL2026-01-08
00810129092585HyperSutureTSS-251CN2025-05-20
00810129092608HyperSutureTSS-516CN2025-05-20
00810129092622HyperSutureTSS-518CN2025-05-20
00810129093728HyperSutureTST-267N2025-05-20
00810129094084HyperSutureTSS-038CN2025-05-20
00810129092370HyperSutureTSS-505CNL2024-12-19
00810129092394HyperSutureTSS-509CNL2024-12-19
00810129092226HyperSutureTST-167N2024-10-24
00810129092233HyperSutureTST-168N2024-10-24
00810129092240HyperSutureTST-169N2024-10-24
00810129090901HyperSutureTSS-025C2024-10-11
00810129090918HyperSutureTSS-026C2024-10-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10705031097414MERSILENEETHICON, LLCGAT2026-08-17
00860424000273SpeedGraft QuadLink TendonJOINT RESTORATION FOUNDATION INCGAT2024-07-15
00860424000280PilotGraft BTB Tendon, 9 mmJOINT RESTORATION FOUNDATION INCGAT2024-07-15
00860424000297PilotGraft BTB Tendon, 11 mmJOINT RESTORATION FOUNDATION INCGAT2024-07-15
00191083047676RapidEase™Rti Surgical, Inc.GAT2023-11-03
00191083047683RapidEase™Rti Surgical, Inc.GAT2023-11-03
00860424000266SpeedGraft Achilles TendonJOINT RESTORATION FOUNDATION INCGAT2022-08-31
00860424000259JRF PilotGraft BTBJOINT RESTORATION FOUNDATION INCGAT2021-04-02
00860424000242JRF VersaGraft 3.5JOINT RESTORATION FOUNDATION INCGAT2018-09-18
14026704426260DEKNATELTELEFLEX INCORPORATEDGAT2017-04-19
14026704427250DEKNATELTELEFLEX INCORPORATEDGAT2017-04-19
00860424000235JRF GraftLink XLJOINT RESTORATION FOUNDATION INCGAT2016-03-30
00889858118491FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117111FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117135FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117159FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117173FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117210FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117234FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117258FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117296FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117333FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117357FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117371FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117432FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117456FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117494FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117517FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117555FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117579FlexiGRAFT®LIFENET HEALTHGAT2015-09-24