UNIESTER

Basic Information

• Brand Name: UNIESTER
• Primary DI: 16285379148923
• Version / Model: DT6303D
• Catalog Number: DT6303D
• Company Name: UNITED MEDICAL INDUSTRIES CO. LTD
• Labeler DUNS: 535040901
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2020-04-30
• Public Version: 2
• Public Version Date: 2021-02-05
• Public Version Status: Update
• Public Device Record Key: f95c0e67-953d-43a7-b361-2633c05e772c

Device Description

Braided, Polyester Synthetic non-absorbable Surgical Sututres / Ligatures

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• 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
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	878.5000	2

GMDN Terms

Code	Name	Definition	Implantable	Status
13906	Polyester suture, non-bioabsorbable, multifilament	A multiple-strand (multifilament), synthetic thread made from a non-bioabsorbable polyester 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.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	06285379148926	GS1
Primary	16285379148923	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K042286	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	0.3	Millimeter

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: – 25 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: – 25 Degrees Celsius