FDA.reportPublic FDA data

Resectoscopy sheath

Primary DI
04059082010755
Brand
Resectoscopy sheath
Company
SOPRO-COMEG GmbH
Model
199 040 514BC
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
FDCRESECTOSCOPE, WORKING ELEMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDCResectoscope, Working ElementGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K971881000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K971881000COMEG RESECTOSCOPE AND LASER-RESECTOSCOPE WORKING ELEMENTS/URETHROTOMES/ELECTRODES/ALBARRAB DEFLECTORSComeg Endoscopy1997-08-12FJL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04059082010755PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04059082010755040590820107554059082010755

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope sheath, reusableA component of a rigid or flexible endoscope assembly designed as a tube through which an endoscope (e.g., hysteroscope) and endoscopic elements are introduced and assembled to create a complete operative endoscopic unit; it is also designed to function as a protective barrier to isolate the endoscope from patient contact and prevent contamination of the endoscope controls during a procedure. It typically contains ports to enable the insertion of instruments (through the endoscope or through independent working channels), insufflation ports, valves and connectors. It is made of plastic and metal materials. 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
04055207063200ERAGONRichard Wolf GmbHFDC2025-10-20
03665415002840Active working element (SIDE load; round ; Fr26 ; WOLF compatible)LAMIDEY NOURY MEDICALFDC2025-10-08
03665415002857Passive working element (SIDE load; round ; Fr26 ; WOLF compatible)LAMIDEY NOURY MEDICALFDC2025-10-08
03665415002888Passive working element UNIV extra length (SIDE LOAD; round; Fr 26; STORZ compatLAMIDEY NOURY MEDICALFDC2025-10-08
03665415002895Active working element UNIV extra length (SIDE LOAD; round; Fr 26; STORZ compatiLAMIDEY NOURY MEDICALFDC2025-10-08
00848657077491AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FDC2025-08-25
03665415002772Bipolar cutting loop / SLIM (round; Fr22)LAMIDEY NOURY MEDICALFDC2025-04-24
03665415002796Active working element (SIDE load; round ; Fr22 ; STORZ compatible)LAMIDEY NOURY MEDICALFDC2025-04-24
03665415002802Passive working element (SIDE load; round ; Fr22 ; STORZ compatible)LAMIDEY NOURY MEDICALFDC2025-04-24
04048438000175NAKarl Storz GmbH & Co. KGFDC2025-03-27
04048438005408n.a.Karl Storz GmbH & Co. KGFDC2024-10-04
04055207056691NARichard Wolf GmbHFDC2024-03-29
04055207056707NARichard Wolf GmbHFDC2024-03-29
04055207057247NARichard Wolf GmbHFDC2024-03-29
04055207057254NARichard Wolf GmbHFDC2024-03-29
04055207057261NARichard Wolf GmbHFDC2024-03-29
04055207057278NARichard Wolf GmbHFDC2024-03-29
04055207057285NARichard Wolf GmbHFDC2024-03-29
04055207057292NARichard Wolf GmbHFDC2024-03-29
04055207057308NARichard Wolf GmbHFDC2024-03-29
04055207057315NARichard Wolf GmbHFDC2024-03-29
04055207057339SHARKRichard Wolf GmbHFDC2024-03-29
00848657018951WA22507D BIPOLAR LOOP 24FR LARGE - 30 DEGREENATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FDC2023-04-24
00848657018982WA22306D BIPOLAR LOOP 24FR - 30 DEGREENATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FDC2023-04-24
00848657019019AED-WA22355C BIPOLAR NEEDLE ELECTRODE 24FR - ANGLE TIPNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FDC2023-04-24
00848657019033AED-WA22557C BUTTON ELECTRODE - BIPOLAR 24FR - 90 DEGREE - PLASMANATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FDC2023-04-24
03665415002253Bipolar electrode / VAPORIZATION (SIDE load; round fitting ; Fr26)LAMIDEY NOURY MEDICALFDC2023-04-21
03665415002277Bipolar cutting loop / THICK (SIDE load; round fitting ; Fr26)LAMIDEY NOURY MEDICALFDC2023-04-21
03665415002291Bipolar cutting loop / THIN (SIDE load; round fitting ; Fr26)LAMIDEY NOURY MEDICALFDC2023-04-21
03665415002413Bipolar electrode / NEEDLE (SIDE LOAD.round fitting ; Fr26)LAMIDEY NOURY MEDICALFDC2023-04-21