FDA.reportPublic FDA data

Distractor Shaver, 5x11mm

Primary DI
81195401225086
Brand
Distractor Shaver, 5x11mm
Company
INTERVENTIONAL SPINE, INC
Model
6192-05
Catalog number
6192-05
Published
2015-09-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
81195401225086PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
8119540122508681195401225086

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
800-497-0484www.cs@i-spineinc.com

Regulatory Flags#

DUNS number
017663522
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
000119540134488 Degree Lordotic, Opticage Expandable Interbody Implant9101-219101-212016-05-25
81195401082986Opticage Expandable Interbody Implant9080-009080-002015-09-14
81195401107962Opticage Expandable Interbody Implant9080-019080-012015-09-14
81195401108648Opticage Expandable Interbody Implant9080-029080-022015-09-14
81195401109393Opticage Expandable Interbody Implant9080-039080-032015-09-14
81195401110900Opticage Expandable Interbody Implant9080-049080-042015-09-14
81195401111686Opticage Expandable Interbody Implant9080-059080-052015-09-14
81195401112362Opticage Expandable Interbody Implant9080-069080-062015-09-14
81195401113048Opticage Expandable Interbody Implant9080-079080-072015-09-14
81195401114724Opticage Expandable Interbody Implant9080-089080-082015-09-14
81195401115400Opticage Expandable Interbody Implant9080-099080-092015-09-14
81195401116186Opticage Expandable Interbody Implant9080-109080-102015-09-14
81195401117862Opticage Expandable Interbody Implant9080-119080-112015-09-14
81195401245886Opticage Expandable Interbody Implant9080-129080-122015-09-23
81195401246562Opticage Expandable Interbody Implant9080-139080-132015-09-23
81195401247248Opticage Expandable Interbody Implant9080-149080-142015-09-23
81195401248924Opticage Expandable Interbody Implant9080-159080-152015-09-23
81195401249600Opticage Expandable Interbody Implant9080-169080-162015-09-23
81195401250286Opticage Expandable Interbody Implant9080-179080-172015-09-23
81195401251962Opticage Expandable Interbody Implant9080-189080-182015-09-23

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