FASTIN ETHIBOND

Basic Information

• Brand Name: FASTIN ETHIBOND
• Primary DI: 10886705008223
• Version / Model: 222720
• Catalog Number: 222720
• Company Name: DEPUY MITEK, LLC
• Labeler DUNS: 190572854
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-01
• Public Version: 5
• Public Version Date: 2019-03-21
• Public Version Status: Update
• Public Device Record Key: ab6e49a4-6be3-4033-8d91-2f113cc93c8e

Device Description

FASTIN RC Anchor with ETHIBOND (1) Green (1) White strand Size 2 (5 metric) ETHIBOND braided polyester suture, 36 Inches (91cm), on disposable inserter.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GAM	SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID	General, Plastic Surgery	878.4493	2
GAS	Suture, nonabsorbable, synthetic, polyester	General, Plastic Surgery	878.5000	2
MBI	FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE	Orthopedic	888.3040	2
HWC	Screw, fixation, bone	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45062	Tendon/ligament bone anchor, non-bioabsorbable	A 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)].	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20886705008220	GS1	PACKAGE	5	In Commercial Distribution
Primary	10886705008223	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K983818	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: High: 25 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: High: 25 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: High: 77 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: High: 77 Degrees Fahrenheit