Greatbatch Steerable Sheath

Primary DI
10821329000420
Brand
Greatbatch Steerable Sheath
Company
Greatbatch Ltd
Model
10876-002
Catalog number
10876-002
Device description
Steerable Sheath, 9 French
Published
2017-10-19
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
DQYCatheter, Percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10821329000420PackageGS11In Commercial Distribution
00821329000423PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1082132900042010821329000420
00821329000423008213290004238213290004230821329000423

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA sterile, flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section of the tube can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended for infusion, is not a microcatheter (i.e., not intended to access superselective small vessels), and does not include a transseptal needle. It may include a disposable percutaneous introduction set. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle180degree
Length67Centimeter
Length86Centimeter
Lumen/Inner Diameter0.9Millimeter
Lumen/Inner Diameter3Millimeter
Outer Diameter3.2Millimeter
Outer Diameter4.3Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
968623467
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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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
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