FDA.report

NA

Primary DI
04055207043530
Brand
NA
Company
Richard Wolf GmbH
Model
8836085
Catalog number
8836.085
Device description
PROCTOSCOPE TUBE Ø 24MM WL 60MM WL 60mm, TL 75mm, straight, reusable
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

Related Records

Contact Domains

Product Codes

CodeName
GCMENDOSCOPE, RIGID

Product Code Classifications

CodeDeviceSpecialtyClass
GCMEndoscope, RigidGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04055207043530PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04055207043530040552070435304055207043530

GMDN Terms

TermDefinition
Proctoscope, reusableAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the rectum and anus. It is inserted into the body through the anus during proctoscopy. Anatomical images are transmitted to the user by the device by direct or magnified viewing. This device is longer than an anoscope to provide a deeper view and it is typically equipped with illumination in the distal end. This is a reusable device.

Device Sizes

TypeValueUnit
Length60Millimeter
Outer Diameter24Millimeter

Sterilization Methods

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

Contacts

PhoneEmail
+497043350info@richard-wolf.com

Regulatory Flags

DUNS number
315304071
Device count
1
DM exempt
false
Premarket exempt
true
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 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 DIBrandCompanyProduct codePublished
00198506001970ELMEDELMED INCORPORATEDGCM2024-04-24
00198506002137ELMEDELMED INCORPORATEDGCM2024-04-24
00198506002243ELMEDELMED INCORPORATEDGCM2024-04-24
00198506002298ELMEDELMED INCORPORATEDGCM2024-04-24
00198506002311ELMEDELMED INCORPORATEDGCM2024-04-24
00842180187597ELMEDELMED INCORPORATEDGCM2024-04-09
00842180185685ELMEDELMED INCORPORATEDGCM2024-02-20
04055207062890PANOVIEW ULTRARichard Wolf GmbHGCM2021-05-25
04055207062913PANOVIEW ULTRARichard Wolf GmbHGCM2021-05-25
04055207062920PANOVIEW ULTRARichard Wolf GmbHGCM2021-05-25
04042761083485OlympusOLYMPUS Winter & Ibe GmbHGCM2020-07-31
04042761083492OlympusOLYMPUS Winter & Ibe GmbHGCM2020-07-31
00842180136014ELMEDELMED INCORPORATEDGCM2019-04-30
00842180135970ELMEDELMED INCORPORATEDGCM2019-04-22
00842180135932ELMEDELMED INCORPORATEDGCM2019-04-15
00842180135949ELMEDELMED INCORPORATEDGCM2019-04-15
00842180135956ELMEDELMED INCORPORATEDGCM2019-04-15
00842180135963ELMEDELMED INCORPORATEDGCM2019-04-15
04055207011652NARichard Wolf GmbHGCM2017-07-21
04055207058015NARichard Wolf GmbHGCM2017-07-21
04055207058022NARichard Wolf GmbHGCM2017-07-21
04055207058039NARichard Wolf GmbHGCM2017-07-21
04055207060513ERAGON MODULARRichard Wolf GmbHGCM2017-07-21
04055207060520ERAGON MODULARRichard Wolf GmbHGCM2017-07-21
04055207060537ERAGON MODULARRichard Wolf GmbHGCM2017-07-21
04055207060544ERAGON MODULARRichard Wolf GmbHGCM2017-07-21
00821925019935FIBER OPTIC LIGHT CABLE 8' LONG 4.0 MM DIAMETERGyrus Acmi, Inc.GCM2017-05-09
04055207020968NARichard Wolf GmbHGCM2016-09-28
04055207020982NARichard Wolf GmbHGCM2016-09-28
04055207020197PANOVIEW PLUSRichard Wolf GmbHGCM2016-09-27