TissueStat

Basic Information

• Brand Name: TissueStat
• Primary DI: 00850061177070
• Version / Model: TIS-044
• Company Name: Durastat LLC
• Labeler DUNS: 080315253
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-03-04
• Public Version: 1
• Public Version Date: 2026-03-12
• Public Version Status: New
• Public Device Record Key: db03df0a-1635-40b3-9bd5-4f4823e063b6

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	878.4493	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17471	Polyester suture, bioabsorbable, multifilament, non-antimicrobial	A multiple-strand (multifilament), synthetic, bioabsorbable thread made from a polyester intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues. The thread provides extended temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850061177070	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K043539	000