Fibrant Instrument Kit

Primary DI
M896IBK00010
Brand
Fibrant Instrument Kit
Company
Arteriocyte Medical Systems, Inc.
Model
IB-K-0001
Catalog number
IB-K-0001
Device description
Fibrant™ Instrumentation Set is a non-sterile, single-use surgical instrument kit used in orthopedic procedures. The kit includes reusable instruments such as awls, a handle, and a graft funnel system, provided in a sterilization tray for organization, storage, and steam sterilization prior to use. The instruments are intended for the preparation of insertion sites and the delivery of bone graft material during surgical procedures.
Published
2022-12-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M896IBK00010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
888-705-4786customerservice@istobiologics.com

Regulatory Flags#

DUNS number
809012870
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Lot or batch
true
Sterilization required before use
true

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