FDA.report

MobiCath™

Primary DI
00846835012371
Brand
MobiCath™
Company
Greatbatch Ltd
Model
D140011
Catalog number
D140011
Device description
MobiCath BiDirectional Guiding Sheath, Large Curve
Published
2016-09-24
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

Related Records

Product Codes

CodeName
DYBIntroducer, Catheter

Product Code Classifications

CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10846835012378PackageGS11In Commercial Distribution
00846835012371PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1084683501237810846835012378
00846835012371008468350123718468350123710846835012371

GMDN Terms

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

TypeValueUnit
Angle150degree
Length3.81Centimeter
Length72Centimeter
Length91.8Centimeter
Length96.4Centimeter
Length180Centimeter
Lumen/Inner Diameter0.0812Centimeter
Lumen/Inner Diameter0.282Centimeter

Storage And Handling

TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods

Method

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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10821329500029Flowguard™10684-00210684-0022016-09-24
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20821329400845RadialSeal™ Introducer Kit, Poly WireSPC-000654-0062018-09-24
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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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