FDA.report

OptiSeal™

Primary DI
10821329600286
Brand
OptiSeal™
Company
Greatbatch Ltd
Model
1000092-002
Device description
Valved Peelable PTFE Introducer
Published
2018-11-26
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
10821329600286PackageGS15In Commercial Distribution
00821329600289PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1082132960028610821329600286
00821329600289008213296002898213296002890821329600289

GMDN Terms

TermDefinition
Vascular catheter introduction set, nonimplantableA collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.

Device Sizes

TypeValueUnit
Catheter Gauge7French
Catheter Inner Diameter2.5Millimeter
Guidewire Length60Centimeter
Length13Centimeter
Lumen/Inner Diameter0.89Millimeter
Needle Gauge18Gauge
Total Volume12Milliliter

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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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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