FDA.reportPublic FDA data

TITAN™ DOUBLE WIRE

Primary DI
00853190008956
Brand
TITAN™ DOUBLE WIRE
Company
JACE MEDICAL, LLC
Model
132.640.63
Device description
"MONOFILAMENT 316 LVMSTAINLESS STEEL SUTURE,BE2 NEEDLE, 65MM, USP 6, 14"", 3 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

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAOSuture, Nonabsorbable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAOSuture, NonabsorbableGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853190008659PackageGS112Not in Commercial Distribution
00853190008956PrimaryGS10
00853190008253Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853190008659008531900086598531900086590853190008659
00853190008956008531900089568531900089560853190008956
00853190008253008531900082538531900082530853190008253

GMDN Terms#

Term, Definition table
TermDefinition
Metallic suture, monofilamentA 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.

Contacts#

Phone, Email table
PhoneEmail
574-306-0355customerservice@jacemed.com

Regulatory Flags#

DUNS number
063554875
Device count
3
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853190008895Universal Plate Cutter215.010.422020-11-06
00851599007136Implant Positioner Handle, Standard215.010.012018-01-26
00850051329069Sternalock EZ315.110.152023-05-26
00853190008741Sternalock EZ115.107.122023-11-20
00851599007945Sternalock EZ315.010.002023-05-26
00853190008789Sternalock EZ115.302.162023-11-20
00853190008796Sternalock EZ115.401.042023-11-20
00851599007396Plate Screw Guide201.025.002016-11-18
00851599007983Sternalock EZ315.010.202023-05-26
00851599007655T15 Hexalobe Drive201.047.152018-01-26
00850051329014Sternalock EZ115.504.122023-11-20
00850051329021Sternalock EZ115.505.122023-11-20
00853190008352Sternalock EZ115.503.082023-11-20
00853190008512Sternalock EZ115.101.042023-11-20
00853190008529Sternalock EZ115.102.062023-11-20
00853190008635Sternalock EZ115.103.042023-11-20
00853190008642Sternalock EZ115.104.062023-11-20
00853190008727Sternalock EZ115.105.102023-11-20
00853190008734Sternalock EZ115.106.102023-11-20
00853190008758Sternalock EZ115.109.082023-11-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10195594085070CARDINAL HEALTHCardinal Health 200, LLCGAO2021-06-04
10841291102069Myo/Wire IIA & E MEDICAL CORPORATIONGAO2018-07-25
10841291102281Myo/Wire IIA & E MEDICAL CORPORATIONGAO2018-05-08
10841291102106Myo/Wire IIA & E MEDICAL CORPORATIONGAO2016-01-13
10841291101727Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-18
10841291101932Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-18
10841291102113Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-18
10841291102212Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-18
10841291101093Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-15
10841291101109Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-15
10841291101116Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-15
10841291101123Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-15
10841291101130Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-15
10841291101147Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-15
10841291101154Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-15
10841291101161Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-15
10841291101178Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-15
10841291101185Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-15
10841291101192Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-15
10841291101208Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-15
10841291101215Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-15
10841291101222Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-15
10841291101239Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-15
10841291101246Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-15
10841291101253Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-15
10841291101260Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-15
10841291101277Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-15
10841291101284Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-15
10841291101291Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-15
10841291101307Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-15