FDA.reportPublic FDA data

Lead Loop

Primary DI
M759LLSD10
Brand
Lead Loop
Company
Suture Concepts Inc.
Model
CAT-LLSD11
Catalog number
CAT-LLSD11
Device description
Suture Concepts Lead Loop Suturing Device
Published
2018-04-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GZBStimulator, Spinal-Cord, Implanted (Pain Relief)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZBStimulator, Spinal-Cord, Implanted (Pain Relief)Neurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150924000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150924000A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (1) plus Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (2), A.I.M. Lead Loop Suturing Device plus Tension Assist/Suture Cutter DeviceAnchor Innovation Medical (A.I.M.)2015-07-27GZB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M759LLSD10PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Neural-tissue electrical stimulation lead adaptorAn implantable device intended to provide a functional and modified connection between existing neurostimulation leads/lead extensions and an implanted replacement neurostimulator [e.g., a spinal cord stimulation (SCS) or a deep brain stimulation (DBS) stimulator]. It typically consists of a small connector block to enable attachment to the existing stimulation leads (i.e., when they do not meet connection design) and connection to the replacement neurostimulator. During implantation, the surgeon uses a tool to tighten the connections (e.g., a Hex wrench) and a medical adhesive to seal the connections from body fluid contamination.

Contacts#

Phone, Email table
PhoneEmail
9789690070orders@sutureconcepts.com

Regulatory Flags#

DUNS number
079749303
Device count
1
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M759CATTFD01Lead LoopCAT-TFD-10CAT-TFD-102018-04-25

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