GYRUS ACMI, INC

Basic Information

• Brand Name: GYRUS ACMI, INC
• Primary DI: 00821925019324
• Version / Model: 143005
• Company Name: Gyrus Acmi, Inc.
• Labeler DUNS: 007198742
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-24
• Public Version: 5
• Public Version Date: 2024-02-14
• Public Version Status: Update
• Public Device Record Key: acb27098-d0a8-4f44-a864-f80601e1fd0a

Device Description

VOCOM SHIM 2 MM OFFSET DENSE HYDROXYLAPATITE

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: Labeling does not contain MRI Safety Information
• 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
KHJ	Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)	Ear, Nose, Throat	874.3620	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60859	Larynx prosthesis	A sterile implantable device intended to replace the larynx to provide normal functionality (i.e., breathing, swallowing, and vocalization) following laryngectomy, usually as a treatment for cancer. It consists of a permanently implanted metal (e.g., titanium) tube, with a temporary silicone tube extension initially implanted to facilitate alignment and tissue integration while the airway is maintained with a tracheostoma. Initially a cap occludes the proximal end of the prosthesis, which is later replaced by a valve-like device; the prosthesis is designed to function without a tracheostoma.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00821925019324	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K974311	000