FDA.report

NA

Primary DI
04055207022085
Brand
NA
Company
Richard Wolf GmbH
Model
8920311
Catalog number
8920.311
Device description
AUTOMATIC VALVE ID 5.7MM reusable
Published
2016-09-28
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
GCJLaparoscope, general & plastic surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04055207022085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04055207022085040552070220854055207022085

GMDN Terms

TermDefinition
Endoscope assembly adaptorA connecting component of a flexible or rigid endoscope assembly intended to be used to join one or more endoscope elements to create a complete endoscope assembly, or to enable the connection of other devices (e.g., a laser). It may also be fitted with stop-cocks or instrument ports for the introduction of devices (e.g., catheters), fluids, gases, or to perform aspiration. This is a reusable device.

Device Sizes

TypeValueUnit
Lumen/Inner Diameter5.7Millimeter

Storage And Handling

TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods

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

Contacts

PhoneEmail
+497043350info@richard-wolf.com

Regulatory Flags

DUNS number
315304071
Device count
1
DM exempt
true
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 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
00850016403179ActivSight Laparoscope 5.5mm 30 Degree NIRActiv Surgical, Inc.GCJ2026-05-26
00850016403186ActivSight Laparoscope 10mm 30 Degree NIRActiv Surgical, Inc.GCJ2026-05-26
00850016403254ActivSight Laparoscope 5.5mm 0 Degree NIRActiv Surgical, Inc.GCJ2026-05-26
00850016403261ActivSight Laparoscope 10mm 0 Degree NIRActiv Surgical, Inc.GCJ2026-05-26
00846159038644SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGCJ2026-05-22
00846159038651SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGCJ2026-05-22
00846159038668SCANLAN® InstrumentsSCANLAN INTERNATIONAL INCGCJ2026-05-22
00846159038675SCANLAN® ClampSCANLAN INTERNATIONAL INCGCJ2026-05-22
00846159038682SCANLAN® ClampSCANLAN INTERNATIONAL INCGCJ2026-05-22
00846159038699SCANLAN® ClampSCANLAN INTERNATIONAL INCGCJ2026-05-22
00846159038705SCANLAN® ClampSCANLAN INTERNATIONAL INCGCJ2026-05-22
00846159038712SCANLAN® ClampSCANLAN INTERNATIONAL INCGCJ2026-05-22
00846159038729SCANLAN® ClampSCANLAN INTERNATIONAL INCGCJ2026-05-22
06972304750407DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.GCJ2026-05-22
06972304750414DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.GCJ2026-05-22
16972304750381DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.GCJ2026-05-22
16972304750398DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.GCJ2026-05-22
16972304750428DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.GCJ2026-05-22
16972304750435DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.GCJ2026-05-22
00190776417895MillenniumAvalign Technologies, Inc.GCJ2026-03-23
00190776418298MillenniumAvalign Technologies, Inc.GCJ2026-03-23
00190776418304MillenniumAvalign Technologies, Inc.GCJ2026-03-23
00190776418311MillenniumAvalign Technologies, Inc.GCJ2026-03-23
00817428021551ModulapATC TECHNOLOGIES, INC.GCJ2026-03-20
10817428021558ModulapATC TECHNOLOGIES, INC.GCJ2026-03-20
00198506089527ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-03-13
10649111501326Sklar InstrumentsSKLAR CORPORATIONGCJ2026-03-12
00190776417840MillenniumAvalign Technologies, Inc.GCJ2026-03-11
00190776417857MillenniumAvalign Technologies, Inc.GCJ2026-03-11
00190776417864MillenniumAvalign Technologies, Inc.GCJ2026-03-11