HyperSuture
GUDID 00810129092622
Needled 36" USP #5 White/Black Polyblend Suture
Threadstone LLC
Polyolefin/fluoropolymer suture, multifilament| Primary Device ID | 00810129092622 |
| NIH Device Record Key | 4e5934d5-5ee0-40f6-8b81-a15b919771ae |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HyperSuture |
| Version Model Number | TSS-518CN |
| Company DUNS | 104319989 |
| Company Name | Threadstone LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 4436886483 |
| order@threadstoneusa.com | |
| Phone | 4436886483 |
| order@threadstoneusa.com | |
| Phone | 4436886483 |
| order@threadstoneusa.com | |
| Phone | 4436886483 |
| order@threadstoneusa.com | |
| Phone | 4436886483 |
| order@threadstoneusa.com | |
| Phone | 4436886483 |
| order@threadstoneusa.com | |
| Phone | 4436886483 |
| order@threadstoneusa.com | |
| Phone | 4436886483 |
| order@threadstoneusa.com | |
| Phone | 4436886483 |
| order@threadstoneusa.com | |
| Phone | 4436886483 |
| order@threadstoneusa.com | |
| Phone | 4436886483 |
| order@threadstoneusa.com | |
| Phone | 4436886483 |
| order@threadstoneusa.com | |
| Phone | 4436886483 |
| order@threadstoneusa.com | |
| Phone | 4436886483 |
| order@threadstoneusa.com | |
| Phone | 4436886483 |
| order@threadstoneusa.com | |
| Phone | 4436886483 |
| order@threadstoneusa.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810129092622 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K230311
FDA Product Code
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-28 |
| Device Publish Date | 2025-05-20 |
On-Brand Devices [HyperSuture]
| 00810129090192 | 40" USP #2 Needled White/Black Polyblend Suture |
| 00810129090598 | 40" 2.0mm Needled White/Black Polyblend Suture Tape |
| 00810129090550 | 40" 2.0mm Needled White UHMWPE Suture Tape |
| 00810129090543 | 40" 2.0mm White/Black Polyblend Suture Tape |
| 00810129090505 | 40" 2.0mm White UHMWPE Suture Tape |
| 00810129090499 | 40" 1.5mm Needled White/Black Polyblend Suture Tape |
| 00810129090451 | 40" 1.5mm Needled White UHMWPE Suture Tape |
| 00810129090444 | 40" 1.5mm White/Black Polyblend Suture Tape |
| 00810129090406 | 40" 1.5mm White UHMWPE Suture Tape |
| 00810129090390 | 40" 0.8mm Needled White/Black Polyblend Suture Tape |
| 00810129090352 | 40" 0.8mm Needled White UHMWPE Suture Tape |
| 00810129090345 | 40" 0.8mm White/Black Polyblend Suture Tape |
| 00810129090307 | 40" 0.8mm White UHMWPE Suture Tape |
| 00810129090291 | 40" USP #5 Needled White/Black UHMWPE Suture |
| 00810129090253 | 40" USP #5 Needled White UHMWPE Suture |
| 00810129090246 | 40" USP #5 White/Black Polyblend Suture |
| 00810129090208 | 40" USP #5 White UHMWPE Suture |
| 00810129090154 | 40" USP #2 Needled White UHMWPE Suture |
| 00810129090147 | 40" USP #2 White/Black Polyblend Suture |
| 00810129090109 | 40" USP #2 White UHMWPE Suture |
| 00810129090093 | 40" USP #2-0 Needled White/Black Polyblend Suture |
| 00810129090055 | 40" USP #2-0 Needled White UHMWPE Suture |
| 00810129090048 | 40" USP #2-0 White/Black Polyblend Suture |
| 00810129090000 | 40" USP #2-0 White UHMWPE Suture |
| 00810129090574 | 40" 2.0mm Needled White/Blue UHMWPE Suture Tape |
| 00810129090567 | 36" 2.0mm Needled Blue UHMWPE Suture Tape |
| 00810129090529 | 40" 2.0mm White/Blue UHMWPE Suture Tape |
| 00810129090512 | 36" 2.0mm Blue UHMWPE Suture Tape |
| 00810129090475 | 40" 1.5mm Needled White/Blue UHMWPE Suture Tape |
| 00810129090468 | 36" 1.5mm Needled Blue UHMWPE Suture Tape |
| 00810129090420 | 40" 1.5mm White/Blue UHMWPE Suture Tape |
| 00810129090413 | 36" 1.5mm Blue UHMWPE Suture Tape |
| 00810129090369 | 40" 0.8mm Needled White/Blue UHMWPE Suture Tape |
| 00810129090314 | 40" 0.8mm Needled White/blue Polyblend Suture Tape |
| 00810129090277 | 36" USP #5 Needled Blue UHMWPE Suture |
| 00810129090260 | 40" USP #5 Needled White/Blue UHMWPE Suture |
| 00810129090222 | 36" USP #5 Blue UHMWPE Suture |
| 00810129090215 | 40" USP #5 White/Blue UHMWPE Suture |
| 00810129090178 | 36" USP #2 Needled Blue UHMWPE Suture |
| 00810129090161 | 40" USP #2 Needled White/Blue UHMWPE Suture |
| 00810129090123 | 36" USP #2 Blue UHMWPE Suture |
| 00810129090116 | 40" USP #2 White/Blue UHMWPE Suture |
| 00810129090062 | 40" USP #2-0 Needled White/Blue UHMWPE Suture |
| 00810129090017 | 40" USP #2-0 White/Blue UHMWPE Suture |
| 00810129092172 | 18" 1.5mm White/Blue/Black Polyblend Whip Stitch Suture |
| 00810129092165 | 18" 1.5mm White/Black Polyblend Whip Stitch Suture |
| 00810129092158 | 18" 1.5mm White/Blue UHMWPE Whip Stitch Suture |
| 00810129092141 | 18" 1.5mm White UHMWPE Whip Stitch Suture |
| 00810129092110 | 18" USP #2 White/Blue UHMWPE Shuttle Stitch Suture |
| 00810129092103 | 18" 2.0mm White/Blue/Black Polyblend Whip Stitch Suture |
Trademark Results [HyperSuture]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HYPERSUTURE 98042302 not registered Live/Pending |
TIGON MEDICAL 2023-06-14 |
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