FDA.reportPublic FDA data

PERPOS FUSION Facet Prep Kit

Primary DI
81195401024948
Brand
PERPOS FUSION Facet Prep Kit
Company
INTERVENTIONAL SPINE, INC
Model
9066-00
Catalog number
9066-00
Device description
1 Funnel Assembly, 1 Plunger Assembly, 2 Raps
Published
2015-09-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
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
81195401024948PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
8119540102494881195401024948

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, single-useA collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
017663522
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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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