FDA.reportPublic FDA data

n.a.

Primary DI
04048551345733
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
488040
Device description
Self-retaining Nasal Retractor
Published
2019-03-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LRCINSTRUMENT, ENT MANUAL SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRCInstrument, Ent Manual SurgicalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048551345733PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551345733040485513457334048551345733

GMDN Terms#

Term, Definition table
TermDefinition
ENT elevatorA hand-held, manually-operated, surgical instrument used to lift, position or pry anatomical structures or surgical material during ear/nose/throat (ENT) surgery. It may be a single or a double-ended device with a blunted blade or hook of various shapes with no cutting edges at the distal working end(s) and a handle positioned centrally or at the proximal end. Its shape and size depends upon the intended use, e.g., a blunt antrum, a rhinology or septum elevator, a strong nasal fracture elevator, or a specially designed ear elevator. It is usually made of high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
315731430
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048551001141n.a.495NCS2016-09-23
04048551004401n.a.495TIP2016-09-23
04048551004463n.a.50200FFL2018-08-21
04048551028568n.a.495ADM2016-09-23
04048551049549n.a.10970AE2018-08-17
04048551049563n.a.10970BE2018-08-17
04048551052495n.a.12016EM2016-09-23
04048551052525n.a.12016FM2016-09-23
04048551052990n.a.12061A2016-09-23
04048551053003n.a.12061AU2016-09-23
04048551053010n.a.12061AV2016-09-23
04048551053027n.a.12061AW2016-09-23
04048551053034n.a.12061AX2016-09-23
04048551053041n.a.12061B2016-09-23
04048551053065n.a.12061C2016-09-23
04048551053072n.a.12061F2016-09-23
04048551053089n.a.12061G2016-09-23
04048551053096n.a.12061H2016-09-23
04048551053102n.a.12061K2016-09-23
04048551082027n.a.233250B2016-09-23

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00198506093623ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-22
04059453127471Hermann Medizintechnik GmbHHermann Medizintechnik GmbHLRC2026-07-16
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