FDA.reportPublic FDA data

Kompressor Compression Screw System

Primary DI
00885556869017
Brand
Kompressor Compression Screw System
Company
Smith & Nephew, Inc.
Model
211910
Catalog number
211910
Device description
MINI COMPRESSION DRIVER
Published
2022-12-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KAZRASP, FRONTAL-SINUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAZRasp, Frontal-SinusEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556869017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556869017008855568690178855568690170885556869017

GMDN Terms#

Term, Definition table
TermDefinition
Frontal sinus file/raspA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth at the distal working end designed to scrape, clean out, and enlarge the frontal sinus cavities during ear/nose/throat (ENT) surgery. It is available in two main designs: 1) a one-piece instrument that has circular cutting ridges at the tip of the curved distal working end and a handle at the proximal end; or 2) a tubular construction that allows for integrated suction (a tube from a suction system is connected to its proximal end) and a rasp (e.g., diamond coating) at the contoured working end. It is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
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
00885554009101NA720770572077052015-08-30
00885556925690NAROB30080ROB300802026-06-04
03596010589101JOURNEY71422274714222742015-08-30
03596010589132JOURNEY71422277714222772015-08-30
03596010000675OXINIUM71343603713436032015-08-30
03596010474148OXINIUM71342800713428002015-08-30
03596010474162OXINIUM71342804713428042015-08-30
03596010474179OXINIUM71342808713428082015-08-30
03596010474209OXINIUM71343200713432002015-08-30
03596010474216OXINIUM71343203713432032015-08-30
03596010474223OXINIUM71343204713432042015-08-30
03596010474230OXINIUM71343208713432082015-08-30
03596010477279OXINIUM71343600713436002015-08-30
03596010477286OXINIUM71343604713436042015-08-30
03596010477293OXINIUM71343608713436082015-08-30
03596010488862OXINIUM71342200713422002015-08-30
03596010544193JOURNEY71461012714610122015-08-30
03596010544209JOURNEY71461013714610132015-08-30
03596010544216JOURNEY71461014714610142015-08-30
03596010544223JOURNEY71461015714610152015-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10381780080190Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAZ2018-09-17
10381780080206Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAZ2018-09-17
24026704505801PILLINGTELEFLEX INCORPORATEDKAZ2018-09-15
24026704506679PILLINGTELEFLEX INCORPORATEDKAZ2018-09-15
24026704527049PILLINGTELEFLEX INCORPORATEDKAZ2018-09-15
10381780190950Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAZ2018-04-02
10381780190967Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAZ2018-04-02
10381780190974Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAZ2018-04-02
10381780190981Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAZ2018-04-02
M2744002341Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAZ2018-04-02
M2744002351Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAZ2018-04-02
M2744002361Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAZ2018-04-02
M2744002371Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAZ2018-04-02
10381780421856Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAZ2018-01-12
10381780421863Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAZ2018-01-12
10381780421870Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAZ2018-01-12
H834203780Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAZ2018-01-12
H834203800Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAZ2018-01-12
H834203820Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAZ2018-01-12
00849233014589Busse Hospital DisposablesROBERT BUSSE & CO., INC.KAZ2016-09-14