FDA.report

ESCALATE

Primary DI
07613252656586
Brand
ESCALATE
Company
Stryker Corporation
Model
IS4113ESC
Catalog number
IS4113ESC
Device description
SPECIALTY LATERAL MASS TEMPLATE
Published
2016-09-24
Public version status
Update
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
NQWORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL

Product Code Classifications

CodeDeviceSpecialtyClass
NQWOrthosis, Spine, Plate, Laminoplasty, MetalOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07613252656586PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07613252656586076132526565867613252656586

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
149183167
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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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