FDA.reportPublic FDA data

Scissors

Primary DI
04059082015941
Brand
Scissors
Company
SOPRO-COMEG GmbH
Model
393 100 200
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HRXARTHROSCOPE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04059082015941PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04059082015941040590820159414059082015941

GMDN Terms#

Term, Definition table
TermDefinition
Flexible endoscopic scissors, reusableA hand-held flexible device used in combination with a dedicated endoscope and intended to cut tissue or sutures during an endoscopic procedure. It is typically constructed of a flexible metal coil or plastic tube whose distal end is equipped with a pair of mechanical (i.e., not electrosurgical) cutting blades operated through a control handle at the proximal end. It is introduced into the body cavity through the working channel of the endoscope. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
507185952
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04059082002743Arthroscope161 191 040BC0012016-09-12
04059082002750Arthroscope161 240 980BC0012016-09-12
04059082002767Arthroscope161 240 982BC0012016-09-12
04059082002774Cystoscope161 271 140BC0012016-12-22
04059082002781Arthroscope161 271 190BC0012016-09-12
04059082002798Arthroscope161 271 192BC0012016-09-12
04059082002811Sinuscope161 271 760BC0012016-09-12
04059082002835Sinuscope161 271 762BC0012016-09-12
04059082002859Sinuscope161 271 765BC0012016-09-12
04059082002866Arthroscope161 271 770BC0012016-09-12
04059082002880Arthroscope161 271 772BC0012016-09-12
04059082002903Arthroscope161 271 775BC0012016-09-12
04059082002927Sinuscope161 271 780BC0012016-09-12
04059082002941Sinuscope161 271 782BC0012016-09-12
04059082002965Sinuscope161 271 785BC0012016-09-12
04059082003115Sinuscope161 401 800BC0012016-09-12
04059082003139Sinuscope161 401 802BC0012016-09-12
04059082003153Sinuscope161 401 803BC0012016-09-12
04059082003160Sinuscope161 401 805BC0012016-09-12
04059082003184Sinuscope161 401 810BC0012016-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809281659387BALEX Bone Expander SystemTaeyeon Medical co.,Ltd.HRX2026-05-11
08809281659301BALEX Bone Expander SystemTaeyeon Medical co.,Ltd.HRX2025-08-22
08809281659325BALEX Bone Expander SystemTaeyeon Medical co.,Ltd.HRX2025-08-22
08809281659370BALEX Bone Expander SystemTaeyeon Medical co.,Ltd.HRX2025-08-22
07613327601695Connected OR HubSTRYKER CORPORATIONHRX2025-06-04
07613327601701SDC4K Information Management SystemSTRYKER CORPORATIONHRX2025-06-04
07613327638448OmnicurveSTRYKER CORPORATIONHRX2024-09-03
08800038059313SYNTH™ STANDARDIMEDICOM CO., LTD.HRX2024-03-25
08800038058187SYNTH™ PLUSIMEDICOM CO., LTD.HRX2024-03-22
08800038058200SYNTH™ PLUSIMEDICOM CO., LTD.HRX2024-03-22
08800038057906MEDINAUT-I(ICD System)IMEDICOM CO., LTD.HRX2024-02-22
08800038057913MEDINAUT-I(ICD System)IMEDICOM CO., LTD.HRX2024-02-22
08800038057920MEDINAUT-I(ICD System)IMEDICOM CO., LTD.HRX2024-02-22
08800038057937MEDINAUT-I(ICD System)IMEDICOM CO., LTD.HRX2024-02-22
08800038057944MEDINAUT-I(ICD System)IMEDICOM CO., LTD.HRX2024-02-22
07613327554649OmnicurveSTRYKER CORPORATIONHRX2023-11-02
08800038056305SYNTH™ BESIMEDICOM CO., LTD.HRX2023-10-31
08800038056312SYNTH™ BESIMEDICOM CO., LTD.HRX2023-10-31
08800038056329SYNTH™ BESIMEDICOM CO., LTD.HRX2023-10-31
08800038056336SYNTH™ BESIMEDICOM CO., LTD.HRX2023-10-31
08800038056343SYNTH™ CDSIMEDICOM CO., LTD.HRX2023-10-31
08800038056145SYNTH™ BESIMEDICOM CO., LTD.HRX2023-10-19
08800038056152SYNTH™ BESIMEDICOM CO., LTD.HRX2023-10-19
08800038056169SYNTH™ BESIMEDICOM CO., LTD.HRX2023-10-19
08800038056176SYNTH™ BESIMEDICOM CO., LTD.HRX2023-10-19
08800038056183SYNTH™ CDSIMEDICOM CO., LTD.HRX2023-10-19
08800038055643SYNTH™ STANDARDIMEDICOM CO., LTD.HRX2023-08-30
08800104089473Tracker Plus Kyphoplasty SystemGS Medical Co., Ltd.HRX2022-10-24
08800104089480Tracker Plus Kyphoplasty SystemGS Medical Co., Ltd.HRX2022-10-24
07613327554663OmnicurveSTRYKER CORPORATIONHRX2022-04-12