SUPOLENE

Basic Information

• Brand Name: SUPOLENE
• Primary DI: E203US90616
• Version / Model: SUPOLENE
• Company Name: Resorba Medical GmbH
• Labeler DUNS: 341053195
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-02-03
• Public Version: 4
• Public Version Date: 2023-10-30
• Public Version Status: Update
• Public Device Record Key: 80afeae1-66aa-44b1-970c-78b5eda16538

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
Primary	E203US90616	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K143582	000