TissueStat
GUDID 00850061177070
TissueStat delivery devices are indicated to aid in suturing as determined by a licensed physician familiar with the possible side effects, typical findings, limitation, indications, and contra-indications of performing such procedures. This device must be loaded with a double-armed 0 PGLA suture attached to 12mm straight needles. The knot pusher is intended to facilitate secure seating of the suture knot.
Durastat LLC
Polyester suture, bioabsorbable, multifilament, non-antimicrobial| Primary Device ID | 00850061177070 |
| NIH Device Record Key | db03df0a-1635-40b3-9bd5-4f4823e063b6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TissueStat |
| Version Model Number | TIS-044 |
| Company DUNS | 080315253 |
| Company Name | Durastat 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 | false |
| 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 | 18008048018 |
| CUSTOMERSERVICE@DURASTAT.COM | |
| Phone | 18008048018 |
| CUSTOMERSERVICE@DURASTAT.COM | |
| Phone | 18008048018 |
| CUSTOMERSERVICE@DURASTAT.COM | |
| Phone | 18008048018 |
| CUSTOMERSERVICE@DURASTAT.COM | |
| Phone | 18008048018 |
| CUSTOMERSERVICE@DURASTAT.COM | |
| Phone | 18008048018 |
| CUSTOMERSERVICE@DURASTAT.COM | |
| Phone | 18008048018 |
| CUSTOMERSERVICE@DURASTAT.COM | |
| Phone | 18008048018 |
| CUSTOMERSERVICE@DURASTAT.COM |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850061177070 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K043539
FDA Product Code
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid |
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 | 2026-03-12 |
| Device Publish Date | 2026-03-04 |
On-Brand Devices [TissueStat]
| B532TIS0030 | The TissueStat Convenience Kit (TIS-003) is a class I suture deployment device that allows healt |
| B532TIS0040 | TissueStat 0 PGLA Kit |
| B532TIS0010 | TissueStat 2-0 PTFE Kit |
| 00850061177087 | 10-CT INNER PACK: TissueStat delivery devices are indicated to aid in suturing as determined by |
| 00850061177070 | TissueStat delivery devices are indicated to aid in suturing as determined by a licensed physici |
| 00850061177056 | TissueStat delivery devices are indicated to aid in suturing as determined by a licensed physici |
| 00850061177049 | 10-CT CASE: TissueStat delivery devices are indicated to aid in suturing as determined by a lice |
Trademark Results [TissueStat]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TISSUESTAT 97614203 not registered Live/Pending |
DURASTAT LLC 2022-09-30 |
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