FDA.reportPublic FDA data

FlexGuard

Primary DI
04250341911572
Brand
FlexGuard
Company
LISA Laser Products GmbH
Model
101 503 631
Device description
Insertion sheath for laser fibres to protect the inner lining of the working channel of an endoskope.
Published
2018-09-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FEDEndoscopic Access Overtube, Gastroenterology-Urology
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FEDEndoscopic Access Overtube, Gastroenterology-UrologyGastroenterology, Urology2
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070924000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070924000FLEXGUARDAllmed Systems, Inc.2007-06-21GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14250341911579PackageGS14In Commercial Distribution
04250341911572PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1425034191157914250341911579
04250341911572042503419115724250341911572

GMDN Terms#

Term, Definition table
TermDefinition
Laser lithotripsy fibre/suction guideA sterile device intended to be inserted through the working channel of a rigid nephroscope during laser lithotripsy to function as a channel for insertion of the laser fibre of an endotherapy laser beam guide, and for removal of debris (e.g., fluid, calculi fragments) when connected to a vacuum source. It typically consists of a thin hollow tube inserted through a handle, which enable entry of the laser fibre and connection to vacuum tubing. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+49555699380info@lisalaser.de

Regulatory Flags#

DUNS number
315026396
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250341904413Sphinx103 001 010103 001 0102026-01-23
04250341908596RevoLix and RevoLix Jr.105 105 3312026-01-23
04250341908695RevoLix DUO105 301 111105 301 1112026-01-23
04250341910285Sphinx Jr.101 203 311101 203 3112026-01-23
04250341910599 OmniGuide RFID Surgical Fibers101 503 xxx101 503 6482026-01-23
04250341910308Sphinx Jr. 103 201 1112026-01-15
04250341911695RevoLix HTL105 401 0102024-04-04
14250341911579FlexGuard101 503 6312018-09-21

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