RESOPREN

Basic Information

• Brand Name: RESOPREN
• Primary DI: E203US771415
• Version / Model: RESOPREN
• Company Name: Resorba Medical GmbH
• Labeler DUNS: 341053195
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-02-01
• Public Version: 3
• Public Version Date: 2023-10-30
• Public Version Status: Update
• Public Device Record Key: a6770d35-7779-4748-8183-b20f95c4f110

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: 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
MXW	Suture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride)	General, Plastic Surgery	878.5010	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38873	Polyvinylidene fluoride suture	A sterile, single-strand (monofilament), synthetic, non-bioabsorbable thread made of polyvinlyidene fluoride intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached needle intended to be disposed of after single use. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress; it can be removed from the tissue once wound healing occurs or allowed to remain in the tissue where it is gradually encapsulated by fibrous connective tissue. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	E203US771415	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K143582	000