Home GUDID 00853190008949 TITAN™ DOUBLE WIRE
Primary DI 00853190008949
Brand TITAN™ DOUBLE WIRE
Company JACE MEDICAL, LLC
Model 132.640.62
Device description "MONOFILAMENT 316 LVMSTAINLESS STEEL SUTURE,BE2 NEEDLE, 65MM, USP 6, 14"", 2 PK"
Published 2021-10-10
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety MR Conditional
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name PTX Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PTX Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00853190008147 Package GS1 12 Not in Commercial Distribution 00853190008949 Primary GS1 0 00853190008253 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00853190008147 00853190008147 853190008147 0853190008147 00853190008949 00853190008949 853190008949 0853190008949 00853190008253 00853190008253 853190008253 0853190008253
GMDN Terms# Term, Definition table Term Definition Metallic suture, monofilament A single-strand (monofilament), non-bioabsorbable wire made of metal (e.g., surgical steel, titanium) intended to join (approximate) the edges of a soft-tissue wound or incision by stitching (e.g., for abdominal wound closure, intestinal anastomosis, hernia repair), or transosseous (through bone) stitching (e.g., sternal closure); it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. It is used primarily in orthopaedic, neurosurgical, and thoracic applications and provides temporary wound support until the wound sufficiently heals to withstand normal stress; it may be retained for permanent support. This is a single-use device.
Regulatory Flags# DUNS number 063554875 Device count 2 Premarket exempt true Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00810020085464 ForceFlex RIVERPOINT MEDICAL, LLC PTX 2022-06-29 00810020085471 ForceFlex RIVERPOINT MEDICAL, LLC PTX 2022-06-29 00810020085488 ForceFlex RIVERPOINT MEDICAL, LLC PTX 2022-06-29 00810020085495 ForceFlex RIVERPOINT MEDICAL, LLC PTX 2022-06-29 00810020085501 ForceFlex RIVERPOINT MEDICAL, LLC PTX 2022-06-29 00810020085518 ForceFlex RIVERPOINT MEDICAL, LLC PTX 2022-06-29 00810020085525 ForceFlex RIVERPOINT MEDICAL, LLC PTX 2022-06-29 00810020085532 ForceFlex RIVERPOINT MEDICAL, LLC PTX 2022-06-29 00810020085549 ForceFlex RIVERPOINT MEDICAL, LLC PTX 2022-06-29 00810020085556 ForceFlex RIVERPOINT MEDICAL, LLC PTX 2022-06-29 00810020085563 ForceFlex RIVERPOINT MEDICAL, LLC PTX 2022-06-29 00810020085570 ForceFlex RIVERPOINT MEDICAL, LLC PTX 2022-06-29 00810020085587 ForceFlex RIVERPOINT MEDICAL, LLC PTX 2022-06-29 00810020085594 ForceFlex RIVERPOINT MEDICAL, LLC PTX 2022-06-29 00810020085600 ForceFlex RIVERPOINT MEDICAL, LLC PTX 2022-06-29 00810020085617 ForceFlex RIVERPOINT MEDICAL, LLC PTX 2022-06-29 00810020085624 ForceFlex RIVERPOINT MEDICAL, LLC PTX 2022-06-29 00810020085631 ForceFlex RIVERPOINT MEDICAL, LLC PTX 2022-06-29 00810020085648 ForceFlex RIVERPOINT MEDICAL, LLC PTX 2022-06-29 00810020085655 ForceFlex RIVERPOINT MEDICAL, LLC PTX 2022-06-29 00810020085662 ForceFlex RIVERPOINT MEDICAL, LLC PTX 2022-06-29 00810020085679 ForceFlex RIVERPOINT MEDICAL, LLC PTX 2022-06-29 00810020085686 ForceFlex RIVERPOINT MEDICAL, LLC PTX 2022-06-29 10810020085461 ForceFlex RIVERPOINT MEDICAL, LLC PTX 2022-06-29 10810020085478 ForceFlex RIVERPOINT MEDICAL, LLC PTX 2022-06-29 10810020085485 ForceFlex RIVERPOINT MEDICAL, LLC PTX 2022-06-29 10810020085492 ForceFlex RIVERPOINT MEDICAL, LLC PTX 2022-06-29 10810020085508 ForceFlex RIVERPOINT MEDICAL, LLC PTX 2022-06-29 10810020085515 ForceFlex RIVERPOINT MEDICAL, LLC PTX 2022-06-29 10810020085522 ForceFlex RIVERPOINT MEDICAL, LLC PTX 2022-06-29
jacemed.com