FDA.reportPublic FDA data

GII ETHIBOND

Primary DI
10886705005376
Brand
GII ETHIBOND
Company
DEPUY MITEK, LLC
Model
216593
Catalog number
216593
Device description
GII SNAP-PAK SNAP-PAK Size 2 (5 metric) green ETHIBOND braided polyester suture, 36 Inches (91cm), double-armed with CP-2 needles
Published
2015-09-01
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
GASSuture, nonabsorbable, synthetic, polyester

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GASSuture, Nonabsorbable, Synthetic, PolyesterGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20886705005373PackageGS15Not in Commercial Distribution
10886705005376PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088670500537320886705005373
1088670500537610886705005376

GMDN Terms#

Term, Definition table
TermDefinition
Tendon/ligament bone anchor, non-bioabsorbableA non-bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)].

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature025 Degrees Celsius
Handling Environment Temperature077 Degrees Fahrenheit
Storage Environment Temperature025 Degrees Celsius
Storage Environment Temperature077 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
190572854
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886705001804QUICKANCHOR ETHIBOND2120322120322015-09-01
10886705002535QUICKANCHOR ETHIBOND2128662128662015-09-01
10886705002542QUICKANCHOR ETHIBOND2128672128672015-09-01
10886705003747NA2145282145282015-09-01
10886705006892NA2198132198132017-03-17
10886705006908NA2198142198142017-03-17
10886705006922NA2198162198162017-03-17
10886705013098INTRAFIX2546032546032015-09-01
10886705013104NA2546042546042015-09-01
10886705013128INTRAFIX2546092546092015-09-01
10886705013531INTRAFIX2546712546712015-09-01
10886705020607FMS DUO2845802845802015-09-01
10886705020614FMS SOLO2845902845902015-09-01
10886705022397INTRAFIX2546532546532015-09-01
10886705023431HEALIX ADVANCE2223352223352015-09-01
10886705023455HEALIX ADVANCE2223332223332015-09-01
10886705023486HEALIX ADVANCE2223342223342015-09-01
10886705002399QUICKANCHOR ETHIBOND2128502128502015-09-01
10886705002405QUICKANCHOR ETHIBOND TAPERCUT2128512128512015-09-01
10886705002443MICROFIX QUICKANCHOR ETHIBOND2128552128552015-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840124521339TopLockFUSION ORTHOPEDICS, LLCGAS2025-08-14
00840124521346TopLockFUSION ORTHOPEDICS, LLCGAS2025-08-14
00840124521353TopLockFUSION ORTHOPEDICS, LLCGAS2025-08-14
00840124521360TopLockFUSION ORTHOPEDICS, LLCGAS2025-08-14
00850012846543RAM® COR-SUTURE® QUICK LOAD®LSI Solutions, Inc.GAS2025-07-28
10850012846540RAM® COR-SUTURE® QUICK LOAD®LSI Solutions, Inc.GAS2025-07-28
00840277408389PolybondRIVERPOINT MEDICAL, LLCGAS2025-06-18
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10840277408386PolybondRIVERPOINT MEDICAL, LLCGAS2025-06-18
10840277408393PolybondRIVERPOINT MEDICAL, LLCGAS2025-06-18
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10840277408416PolybondRIVERPOINT MEDICAL, LLCGAS2025-06-18
10840277408423RiverbondRIVERPOINT MEDICAL, LLCGAS2025-06-18
10840277408430RiverbondRIVERPOINT MEDICAL, LLCGAS2025-06-18
10840277408447RiverbondRIVERPOINT MEDICAL, LLCGAS2025-06-18
10840277408454RiverbondRIVERPOINT MEDICAL, LLCGAS2025-06-18
10840277409130PolyBondRIVERPOINT MEDICAL, LLCGAS2025-06-18