Home GUDID 00850000630048 SuperBall-RC 12 degrees Down
Primary DI 00850000630048
Brand SuperBall-RC 12 degrees Down
Company ARCURO MEDICAL LTD
Model A
Published 2025-07-08
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Safe
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name GAT Suture, Nonabsorbable, Synthetic, Polyethylene MBI Fastener, Fixation, Nondegradable, Soft Tissue
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery 2 MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850000630048 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00850000630048 00850000630048 850000630048 0850000630048
GMDN Terms# Term, Definition table Term Definition 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.
Sterilization Methods# Method table Method Ethylene Oxide
Regulatory Flags# DUNS number 600664454 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label true No natural rubber latex true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00850000630055 SuperBall-RC 18 degrees Down A SBD-SB-RC-18D 2025-07-08 00850000630024 SuperBall 24 degrees Up A SBD-SB-12-024 2025-06-30 00850000630031 SuperBall 12 degrees Reverse A SBD-SB-12-012 2025-06-30 00850000630017 SuperBall B SBD-SB-12-001 2020-06-15
Other Devices Sharing Product Codes#