Algovita®

Primary DI
00821329580420
Brand
Algovita®
Company
Greatbatch Ltd
Model
5500-USA
Catalog number
5500
Device description
Torque Wrench
Published
2015-12-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
10821329580427PackageGS14In Commercial Distribution
00821329580420PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1082132958042710821329580427
00821329580420008213295804208213295804200821329580420

GMDN Terms#

Term, Definition table
TermDefinition
Neurosurgical procedure kit, non-medicated, single-useA collection of various sterile neurosurgical instruments, dressings and the necessary materials used to perform a neurosurgical procedure. It does not contain pharmaceuticals. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Regulatory Flags#

DUNS number
968623467
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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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
00821329000416Greatbatch Steerable Sheath10876-00110876-0012017-10-19
00821329000423Greatbatch Steerable Sheath10876-00210876-0022017-10-19
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
00821329000485RadialSeal™ Introducer Kit, Poly WireSPC-000654-0092018-09-24
00821329000508PTFE Peelable Introducer Kit667131-35171312017-10-26
00821329000515PTFE Peelable Introducer Kit667133-35171332017-10-26
00821329000522PTFE Peelable Introducer Kit667090-35170902017-10-26
00821329000539PTFE Peelable Introducer Kit667096-35170962017-10-26
00821329000546PTFE Peelable Introducer Kit667097-35170972017-10-26
00821329000553PTFE Peelable Introducer Kit667099-35170992017-10-26

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