FDA.reportPublic FDA data

Spine Needle and Cannula

Primary DI
05060696460088
Brand
Spine Needle and Cannula
Company
MORGAN STEER ORTHOPAEDICS LIMITED
Model
SCL600-01
Device description
Crawford 17 ga x 6” cannula (1)
Published
2024-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061259000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061259000MODIFICATION TO ARTHROCARE PERC-D SPINEWANDArthrocare Corp.2006-05-18GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060696460088PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060696460088050606964600885060696460088

GMDN Terms#

Term, Definition table
TermDefinition
Needle guide, single-useA rigid, non-powered device designed to direct a sharp needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for different procedures such as urethral injections, image-guided (e.g., ultrasound, MRI) transrectal/transperineal prostate biopsy or ablation, endocavity IVF procedures, percutaneous punctures, nerve blocks, electromagnetic device tracking surgery, and stereotactic breast biopsies. Procedural supportive devices (e.g., ultrasound transducer cover/sheath, drape) may be included with the device. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
216776681
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060696460002SpineWandK7920-012024-06-03
05060696460019SpineWandK7925-012024-06-03
05060696460026SpineWandSDC01-012024-06-03
05060696460033SpineWandSDC03-012024-06-03
05060696460040SpineWandSDLG03-012024-06-03
05060696460057SpineWandSDLR03-012024-06-03
05060696460064Spine Needle and CannulaKNS-1706-102024-06-03
05060696460071Spine Needle and CannulaKNS-1904-102024-06-03
05060696460095Spine Needle and CannulaSCL800-012024-06-03

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