FDA.report

PILLING

Primary DI
14026704658463
Brand
PILLING
Company
TELEFLEX INCORPORATED
Model
IPN008828
Catalog number
528305XLTP
Device description
XENALIGHT XLT ll LIGHTSOURCE W/TURRET
Published
2019-05-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FQPLamp, operating-room

Product Code Classifications

CodeDeviceSpecialtyClass
FQPLamp, Operating-RoomGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
14026704658463PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1402670465846314026704658463

GMDN Terms

TermDefinition
General-purpose light sourceA mains electricity (AC-powered) device designed to produce light of high intensity, often called cold light, for various patient examination and procedure applications. Light transfer occurs either directly or through a fibreoptic-light cable connecting this device to an attached device (e.g., headlight, microscope, or endoscope).

Sterilization Methods

Method

Contacts

PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags

DUNS number
002348191
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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30841156103983SUPERCROSS530253022026-03-23
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Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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06974539960002SAIKANGJiangsu Saikang Medical Equipment Co.,Ltd.FQP2023-05-31
00887761976450Pre-Install Set Helux ProBaxter Medical Systems GmbH + Co. KGFQP2023-03-07
00887761976474Helux Pro Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-03-07
00887761977334Helux Pro Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-03-07
00887761977341Helux Pro Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-03-07
00887761977358Helux Pro Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-03-07
00887761977365Helux Pro Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-03-07
00887761977389Helux Pro Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-03-07
00887761968493VidiaPortBaxter Medical Systems GmbH + Co. KGFQP2023-01-17
00887761968325iLED7 Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761970939Carbon SectionsBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761972872Head-Positioning accessoriesBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761972889Head-Positioning accessoriesBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761974432Control UnitsBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761968394TL 5000/3000 – Surgical LightTRUMPF Medizin Systeme GmbH + Co. KGFQP2023-01-05
00887761972902Head-Positioning accessoriesTRUMPF Medizin Systeme GmbH + Co. KGFQP2023-01-05
00887761972926Head-Positioning accessoriesTRUMPF Medizin Systeme GmbH + Co. KGFQP2023-01-05
00887761972957Head-Positioning accessoriesTRUMPF Medizin Systeme GmbH + Co. KGFQP2023-01-05
00887761968127Pre-Install SetBaxter Medical Systems GmbH + Co. KGFQP2022-12-15
00887761968271iLED7 Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2022-12-15
00887761980112TRUMPF MEDICALTRUMPF Medizin Systeme GmbH + Co. KGFQP2022-11-29
00887761980181Hillrom™TRUMPF Medizin Systeme GmbH + Co. KGFQP2021-07-06
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14026704658395PILLINGTELEFLEX INCORPORATEDFQP2019-05-09
14026704658401PILLINGTELEFLEX INCORPORATEDFQP2019-05-09
14026704658418PILLINGTELEFLEX INCORPORATEDFQP2019-05-09
14026704658470PILLINGTELEFLEX INCORPORATEDFQP2019-05-09
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