FDA.reportPublic FDA data

SinuFIT

Primary DI
04048551002919
Brand
SinuFIT
Company
Karl Storz GmbH & Co. KG
Model
449202ZY
Device description
SinuFIT Nasal Scissors Insert,right,17cm
Published
2018-09-04
Public version status
New
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
04048551002919PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551002919040485510029194048551002919

GMDN Terms#

Term, Definition table
TermDefinition
Nasal scissorsA hand-held, manual, surgical instrument used to cut tissue during ear/nose/throat (ENT) or plastic surgery in or on the nose and its associated structures. It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is typically made of high-grade stainless steel and is available in various designs and sizes, usually having slender, pointed blades set at an angle to the handles. Some types can have carbide inserts along the cutting edges. 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
Serial number
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776426637MillenniumAvalign Technologies, Inc.LRC2026-08-19
00190776426347MillenniumAvalign Technologies, Inc.LRC2026-08-18
00844505014786FEATHERVAC, ECLIPSEGrace Medical, Inc.LRC2026-08-18
00844505014793FEATHERVAC, ECLIPSE FLAT RIBBONGrace Medical, Inc.LRC2026-08-18
04054462901142evonosevonos GmbH & Co. KGLRC2026-08-18
04054462901159evonosevonos GmbH & Co. KGLRC2026-08-18
04054462901166evonosevonos GmbH & Co. KGLRC2026-08-18
04054462901180evonosevonos GmbH & Co. KGLRC2026-08-18
04054462902170evonosevonos GmbH & Co. KGLRC2026-08-18
04054462902187evonosevonos GmbH & Co. KGLRC2026-08-18
00190776423704MillenniumAvalign Technologies, Inc.LRC2026-08-07
00190776423711MillenniumAvalign Technologies, Inc.LRC2026-08-07
00190776423728MillenniumAvalign Technologies, Inc.LRC2026-08-07
00190776424374MillenniumAvalign Technologies, Inc.LRC2026-08-07
00190776424381MillenniumAvalign Technologies, Inc.LRC2026-08-07
00190776424398MillenniumAvalign Technologies, Inc.LRC2026-08-07
00190776422653MillenniumAvalign Technologies, Inc.LRC2026-08-03
00190776422660MillenniumAvalign Technologies, Inc.LRC2026-08-03
00190776422684MillenniumAvalign Technologies, Inc.LRC2026-08-03
00190776422462MillenniumAvalign Technologies, Inc.LRC2026-07-31
00190776422523MillenniumAvalign Technologies, Inc.LRC2026-07-31
00190776422585MillenniumAvalign Technologies, Inc.LRC2026-07-31
09348811102645INKAThe Trustee for KAISER FAMILY TRUSTLRC2026-07-31
09348811102669INKAThe Trustee for KAISER FAMILY TRUSTLRC2026-07-31
00198506093593ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-29
00198506093777ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-29
00198506093807ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-29
00198506093814ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-29
B382SD9200321000Surgical DirectSurgical Direct, Inc.LRC2026-07-29
B382SD9200321060Surgical DirectSurgical Direct, Inc.LRC2026-07-29