FDA.reportPublic FDA data

Greatbatch Steerable Sheath

Primary DI
10821329000413
Brand
Greatbatch Steerable Sheath
Company
Greatbatch Ltd
Model
10876-001
Catalog number
10876-001
Device description
Steerable Sheath, 8 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
10821329000413PackageGS11In Commercial Distribution
00821329000416PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1082132900041310821329000413
00821329000416008213290004168213290004160821329000416

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 Diameter2.5Millimeter
Outer Diameter2.8Millimeter
Outer Diameter3.8Millimeter

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00821329400339Capella™1012868-005MK51822016-04-05
00821329400346Capella™1012868-006MK51832016-04-05
08714729862413Boston Scientific Channel Steerable SheathM004CS100M004CS1002016-09-24
08714729862420Boston Scientific Channel Steerable SheathM004CS200M004CS2002016-09-24
10821329400381LI Plus 4176724176722016-10-31
10821329400398LI Plus 4176734176732016-10-31
10821329400411LI Plus 4176754176752016-10-31
10821329500074Flowguard™10684-00510684-0052016-09-24
10821329500029Flowguard™10684-00210684-0022016-09-24
10821329600378ViaPeel™10893-00210893-0022016-10-31
20821329400845RadialSeal™ Introducer Kit, Poly WireSPC-000654-0062018-09-24
20821329000670OptiSeal™ 1000092-0011000092-0012019-08-15
20821329000687OptiSeal™ 1000092-0021000092-0022019-08-15
20821329000694OptiSeal™ 1000092-0031000092-0032019-08-15
20821329000700OptiSeal™ 1000092-0041000092-0042019-08-15
00821329000713OptiSeal™ 1000093-001 1000093-001 2019-08-15
20821329000724OptiSeal™ 1000093-002 1000093-002 2019-08-15
20821329000731OptiSeal™ 1000093-003 1000093-003 2019-08-15
20821329000748OptiSeal™ 1000093-004 1000093-004 2019-08-15
20821329000755OptiSeal™ 1000093-005 1000093-005 2019-08-15

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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