FDA.reportPublic FDA data

Myo/Wire II

Primary DI
10841291102403
Brand
Myo/Wire II
Company
A & E MEDICAL CORPORATION
Model
045-006
Device description
SS Suture, 6 per sleeve
Published
2015-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
GAOSuture, Nonabsorbable

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K932513000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K932513000LABELING FOR MYO/WIRE II STERNOTOMY SUTURESAlto Development Corp.1994-01-07GAO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841291102403PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084129110240310841291102403

GMDN Terms#

Term, Definition table
TermDefinition
Metallic suture, monofilamentA sterile, single-strand (monofilament), non-bioabsorbable wire made of metal (e.g., surgical steel, titanium, tantalum) 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 needle intended to be disposed of after single use. 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.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
173770868
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841291105305Myo/Wire021-0112016-03-21
08718627410004MYO/Wire® Ultra-Thin Temporary Pacing Wires AU0101022015-11-05
08718627410028MYO/Wire® Ultra-Thin Temporary Pacing Wires BM1804ABB2015-11-10
08718627410042MYO/Wire® Ultra-Thin Temporary Pacing Wires BM1804ABBN2015-11-10
08718627410066MYO/Wire® Ultra-Thin Temporary Pacing Wires BM2004ABB2015-11-10
08718627410080MYO/Wire® Ultra-Thin Temporary Pacing Wires BM2004ABBD2015-11-10
08718627410103MYO/Wire® Ultra-Thin Temporary Pacing Wires BM2008ABBSN2015-11-10
08718627410127MYO/Wire® Ultra-Thin Temporary Pacing Wires BM2504ABB2015-11-10
08718627410141MYO/Wire® Ultra-Thin Temporary Pacing Wires BM2504ABBD2015-11-10
08718627410165MYO/Wire® Ultra-Thin Temporary Pacing Wires BM2504AWWD2015-11-10
08718627410189MYO/Wire® Ultra-Thin Temporary Pacing Wires BM604ABB2015-11-10
08718627410226MYO/Wire® Ultra-Thin Temporary Pacing Wires BM604ABBDS2015-11-10
08718627410264MYO/Wire® Ultra-Thin Temporary Pacing Wires BM604ABBSTR2015-11-10
08718627410288MYO/Wire® Ultra-Thin Temporary Pacing Wires BM604ABW2015-11-10
08718627410301MYO/Wire® Ultra-Thin Temporary Pacing Wires BM604ACBBGSTR2015-11-10
08718627410325MYO/Wire® Ultra-Thin Temporary Pacing Wires BM604ACWWStr2015-11-10
08718627410349MYO/Wire® Ultra-Thin Temporary Pacing Wires BM604PBB2015-11-10
08718627410363MYO/Wire® Ultra-Thin Temporary Pacing Wires BM604PWWMSTR2015-11-10
08718627410387MYO/Wire® Ultra-Thin Temporary Pacing Wires BM608-12ABBG2015-11-05
08718627410400MYO/Wire® Ultra-Thin Temporary Pacing Wires BM608-8ACBB2015-11-05

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