FDA.report

SureLOK MIS 3L

Primary DI
00840019936552
Brand
SureLOK MIS 3L
Company
PRECISION SPINE, INC.
Model
63-8100-CA-02
Catalog number
63-8100-CA-02
Device description
Instrument Case BOM (Side Load Rod Inserter)
Published
2019-08-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
MNHOrthosis, Spondylolisthesis Spinal Fixation

Product Code Classifications

CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840019936552PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840019936552008400199365528400199365520840019936552

GMDN Terms

TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary 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 reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
079398589
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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