FDA.reportPublic FDA data

GII QUICKANCHOR ETHIBOND

Primary DI
10886705001828
Brand
GII QUICKANCHOR ETHIBOND
Company
Medos International Sàrl
Model
212034
Catalog number
212034
Device description
GII QUICKANCHOR Plus Size 2 (5 metric) green ETHIBOND braided polyester suture, 36 Inches (91cm), double-armed with CP-2 needles, with disposable inserter.
Published
2015-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDRSTAPLE, FIXATION, BONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDRStaple, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K041115000
K902751000
K915889000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041115000GII QUICKANCHOR PLUSDepuy Mitek, A Johnson & Johnson Company2004-05-28JDR
K902751000MITEK ANCHOR IIMitek Surgical Products, Inc.1990-07-24JDR
K915889000MITEK BONE ANCHOR, MODIFICATIONMitek Surgical Products, Inc.1992-10-22JDR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886705001828PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670500182810886705001828

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
482661753
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034581835ROBOTIC INTEGRATION INSTRUMENTS2914-89-0012914890012025-04-17
10705034581842ROBOTIC INTEGRATION INSTRUMENTS2914-89-0022914890022025-04-17
10705034602349ROBOTIC INTEGRATION INSTRUMENTS2914-89-4032914894032025-04-17
10705034602424ROBOTIC INTEGRATION INSTRUMENTS2914-89-4012914894012025-04-17
10705034602462ROBOTIC INTEGRATION INSTRUMENTS2914-89-0002914890002025-04-17
10705034643243VELYS4516110384516110382025-03-28
10705034643250VELYS4516110504516110502025-03-28
10705034643274VELYS4516110214516110212025-03-28
10705034643281VELYS4516110554516110552025-03-28
10705034643298VELYS4516110474516110472025-03-28
10705034643304VELYS4516110464516110462025-03-28
10705034643328VELYS4516110404516110402025-03-28
10705034643342VELYS4516110624516110622025-03-28
10705034643359VELYS4516110454516110452025-03-28
10705034643366VELYS4516110444516110442025-03-28
10705034643373VELYS4516110434516110432025-03-28
10705034643380VELYS4516110414516110412025-03-28
10705034643397VELYS4516110614516110612025-03-28
10705034643403VELYS4516110224516110222025-03-28
10705034643410VELYS4516110234516110232025-03-28

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10886705001033LUPINEDEPUY MITEK, LLCJDR2025-03-04
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