FDA.reportPublic FDA data

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

Other Devices From This Company#

Primary DI, Brand, Model table
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M896AMS3501Basic One Source KitAMS350AMS3502016-09-12
M896AMS1000Magellan Autologous Platelet Separator SystemAMS100AMS1002016-09-09
M896AMS3000Magellan Complete Disposable KitAMS300AMS3002016-09-12
M896AMS3050Magellan Basic disposable kitAMS305AMS3052016-09-12
M896AMS3100Magellan Complete One Source KitAMS310AMS3102016-09-12
M896BTI2000Magellan Autologous Platelet Separator SystemBTI200BTI2002016-09-09
M896CLPTPK1010CP Disposable KitCLPT-PK-101CLPT-PK-1012018-12-12
M896CLPTPK101450Cellpoint CP Disposable Kit with 45mm Lightning NeedleCLPT-PK-101-45CLPT-PK-101-452020-02-26
M896IBIA55600Small Anchor Awl 5mmIB-IA-5560IB-IA-55602022-12-19
M896IBIA65700Medium Anchor Awl 6mmIB-IA-6570IB-IA-65702022-12-19
M896IBIA75800Large Anchor Awl 7mmIB-IA-7580IB-IA-75802022-12-19
M896IBIA85900Xlarge Anchor Awl 8mmIB-IA-8590IB-IA-85902022-12-19
M896IQSPMX1500InQu Matrix 5x10cmIQSP-MX-150IQSP-MX-1502022-06-23
M896IQSPPP1010InQu Paste Mix Plus 1.25ccIQSP-PP-101IQSP-PP-1012018-08-01
M896IQSPPP1020InQu Paste Mix Plus 2.5ccIQSP-PP-102IQSP-PP-1022018-08-01
M896IQSPPP1050InQu Paste Mix Plus 5ccIQSP-PP-105IQSP-PP-1052018-08-01
M896IQSPPP1100InQu Paste Mix Plus 10ccIQSP-PP-110IQSP-PP-1102018-08-01
M896MAG1000Magellan Autologous Platelet Separator SystemMAG100MAG1002016-09-09
M896MAG2000Magellan Autologous Platelet Separator SystemMAG200MAG2002016-09-09
M896MAR0MAX450Magellan MAR0Max QuickDraw Convenience KitMAR0Max45MAR0Max452016-09-09

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