FDA.reportPublic FDA data

E-LINE

Primary DI
04055207027912
Brand
E-LINE
Company
Richard Wolf GmbH
Model
86500545
Catalog number
8650.0545
Device description
SHEATH FOR CYSTOSCOPE 23FR color code white, SL 231mm, oval, slanted distal end, capacity for instruments up to 12Fr or 2x7Fr, compatible with attach
Published
2016-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FDCRESECTOSCOPE, WORKING ELEMENT

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04055207027912PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055207027912040552070279124055207027912

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter7.66666666666Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method
Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+497043350info@richard-wolf.com

Regulatory Flags#

DUNS number
315304071
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04055207069226NA1006921006922026-03-12
04055207069257NA1006981006982026-03-12
04055207068243VERTEBRIS89250643892506432026-02-10
04055207069691NA8922090328922090322026-02-10
04055207069707NA8922090228922090222026-02-10
04055207069714NA8922090238922090232026-02-10
04055207069721NA8922090338922090332026-02-10
04055207069738NA89220922892209222026-02-10
04055207069745NA89220923892209232026-02-10
04055207069790NA8924084158924084152026-01-14
04055207069806NA8924084128924084122026-01-14
04055207069813NA8924084228924084222026-01-14
04055207069820NA8924084258924084252026-01-14
04055207069837NA8924089228924089222026-01-14
04055207069851NA8924089258924089252026-01-14
04055207036693POWER STICK M5/0899550000189955000012025-12-18
04055207000328NA20301052030.1052023-01-11
04055207067987VERTEBRIS8922012788922012782025-11-17
04055207067994VERTEBRIS8922020078922020072025-11-17
04055207068007VERTEBRIS8922020088922020082025-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848657077491AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FDC2025-08-25
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
04055207019603SHARKRichard Wolf GmbHFDC2023-03-07
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04050659367869mahe medical GmbHmahe medical gmbhFDC2019-11-05
04050659371477mahe medical GmbHmahe medical gmbhFDC2019-11-05
04050659371484mahe medical GmbHmahe medical gmbhFDC2019-11-05
04050659371606mahe medical GmbHmahe medical gmbhFDC2019-11-05
04050659372108mahe medical GmbHmahe medical gmbhFDC2019-11-05
04050659372191mahe medical GmbHmahe medical gmbhFDC2019-11-05
04050659373532mahe medical GmbHmahe medical gmbhFDC2019-11-05
04050659373549mahe medical GmbHmahe medical gmbhFDC2019-11-05
04050659373556mahe medical GmbHmahe medical gmbhFDC2019-11-05
04050659376205mahe medical GmbHmahe medical gmbhFDC2019-11-05
04050659376212mahe medical GmbHmahe medical gmbhFDC2019-11-05
04050659376229mahe medical GmbHmahe medical gmbhFDC2019-11-05