FDA.reportPublic FDA data

Algovita®

Primary DI
00821329580024
Brand
Algovita®
Company
Greatbatch Ltd
Model
1081-45-USA
Catalog number
1081-45
Device description
Algovita® 8-Electrode Percutaneous Lead Kit - (compact). Electrode spacing 1 mm
Published
2015-12-01
Public version status
Update
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
LGWStimulator, Spinal-Cord, Totally Implanted For Pain Relief

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGWStimulator, Spinal-Cord, Totally Implanted For Pain ReliefUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821329580024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821329580024008213295800248213295800240821329580024

GMDN Terms#

Term, Definition table
TermDefinition
Analgesic spinal cord electrical stimulation systemAn assembly of devices that applies an electrical stimulus to all or part of the spinal cord to relieve pain (analgesia). It includes an implanted lead/electrode system located in the epidural space of the spinal cord attached to either an implanted passive electronic circuit into which signals and/or energy is inductively coupled from outside the body, or to a totally implantable self-contained system that carries its own energy source and has no inherent dependence upon external devices. It is used to treat acute and/or chronic intractable pain, where the use of drug therapy is undesirable or no longer effective.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length45Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
968623467
Device count
1
Kit
true
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
00821329580499Algovita®5208-20-USA5208-202015-12-01
00821329580505Algovita®5208-40-USA5208-402015-12-01
00821329580512Algovita®5208-60-USA5208-602015-12-01
00821329580529Algovita®5212-20-USA5212-202015-12-01
00821329580536Algovita® 5212-40-USA5212-402015-12-01
00821329580543Algovita® 5212-60-USA5212-602015-12-01
00821329900204Myopore® Sutureless Myocardial Pacing Lead5112102015-05-21
00821329900228Myopore® Sutureless Myocardial Pacing Lead5112122015-05-21
00821329900211Myopore® Sutureless Myocardial Pacing Lead5112112015-05-21
00821329000317PTFE Peelable Introducer Kit1000558-00170872018-09-24
00821329000324PTFE Peelable Introducer Kit667088-35170882017-10-26
00821329000331PTFE Peelable Introducer Kit667087-35170872017-10-26
00821329000348PTFE Peelable Introducer Kit667089-35170892017-10-26
00821329000355PTFE Peelable Introducer Kit667091-35170912017-10-26
00821329000362PTFE Peelable Introducer Kit667093-35170932017-10-26
00821329000430RadialSeal™ Introducer Kit, SS WireSPC-000653-0072018-09-24
00821329000447RadialSeal™ Introducer Kit, SS WireSPC-000653-0092018-09-24
00821329000454RadialSeal™ Introducer Kit, SS WireSPC-000653-0082018-09-24
00821329000461RadialSeal™ Introducer Kit, Poly WireSPC-000654-0072018-09-24
00821329000478RadialSeal™ Introducer Kit, Poly WireSPC-000654-0082018-09-24

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Primary DI, Brand, Company table
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08714729789567Linear™ 3-6BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-12-14
08714729789581Linear™ 3-4BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-12-14
08714729797807Infinion™ 16BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-12-14
08714729797814Infinion™ 16BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-12-14
08714729797821Infinion™ 16BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-12-14
08714729797838NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-12-14
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