FDA.reportPublic FDA data

HyperSuture

Primary DI
00810129091007
Brand
HyperSuture
Company
Threadstone LLC
Model
TSS-205C
Device description
"36"" USP #2 White UHMWPE Suture"
Published
2024-10-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
K230311000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230311000HyperSutureThreadstone, LLC2023-11-24GAT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810129091007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810129091007008101290910078101290910070810129091007

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
4436886483order@threadstoneusa.com

Regulatory Flags#

DUNS number
104319989
Device count
1
Lot or batch
true
Manufacturing date on label
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
00810129094480HyperSutureTST-178NTST-178N2026-04-07
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07649990202419Drill S-PI-A1.6 extra shortSurgical Fusion Technologies GmbHGAT2026-01-18
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
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