FDA.reportPublic FDA data

NA

Primary DI
04055207014967
Brand
NA
Company
Richard Wolf GmbH
Model
8379672
Catalog number
8379.672
Device description
PROBE 3.5MM WL 250MM graduated, reusable
Published
2024-08-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FGMPROBE AND DIRECTOR, GASTRO-UROLOGY
NWVLaparoscopic accessories, gynecologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGMProbe And Director, Gastro-UrologyGastroenterology, Urology1
NWVLaparoscopic Accessories, GynecologicObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04055207014967PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055207014967040552070149674055207014967

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic surgical probeA slender, rod-like, hand-held manual surgical instrument intended to be inserted through an endoscope (e.g., arthroscope, laparoscope) to explore, measure, and/or perform therapeutic procedures during various types of surgical interventions (excludes cryosurgery). It is made of metallic and/or synthetic polymer material. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length250Millimeter

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
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
315304071
Device count
1
Premarket exempt
true
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
04055207011478NA8863758863.752026-05-19
04055207011539NA8913608913.602026-05-19
04055207054390NA417022284170.22282026-05-19
04055207048788NA484076448407642026-05-13
04055207008881NA8061168061.162016-09-23
04055207008898NA8061258061.252016-09-23
04055207008904NA8061358061.352016-09-23
04055207008911NA8062358062.352016-09-23
04055207012611NA40702534070.2532016-09-23
04055207013823NA80611638061.1632016-09-23
04055207013830NA80612538061.2532016-09-23
04055207013854NA80613538061.3532016-09-23
04055207013861NA80613568061.3562016-09-23
04055207013878NA80614538061.4532016-09-23
04055207013885NA80614568061.4562016-09-23
04055207013892NA80614578061.4572016-09-23
04055207013908NA80618538061.8532016-09-23
04055207013922NA80622518062.2512016-09-23
04055207013939NA80623518062.3512016-09-23
04055207013946NA80624518062.4512016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776421601MillenniumAvalign Technologies, Inc.NWV2026-05-05
00190776421250MillenniumAvalign Technologies, Inc.NWV2026-05-04
00190776421076MillenniumAvalign Technologies, Inc.NWV2026-04-30
00848657078368AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2026-04-23
00190776420277MillenniumAvalign Technologies, Inc.NWV2026-04-16
00190776418991MillenniumAvalign Technologies, Inc.NWV2026-04-13
00190776418427MillenniumAvalign Technologies, Inc.NWV2026-03-25
00190776418434MillenniumAvalign Technologies, Inc.NWV2026-03-25
00190776418441MillenniumAvalign Technologies, Inc.NWV2026-03-25
00192896122826Barr ProbeSONTEC INSTRUMENTS, INC.FGM2026-03-10
00848657078269AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2026-03-02
00190776417390MillenniumAvalign Technologies, Inc.NWV2026-02-27
00190776417406MillenniumAvalign Technologies, Inc.NWV2026-02-27
00190776417451MillenniumAvalign Technologies, Inc.NWV2026-02-27
00198506088520ELMED INCORPORATEDELMED INCORPORATEDNWV2026-02-23
00190776416201MillenniumAvalign Technologies, Inc.FGM2026-02-12
00190776416072MillenniumAvalign Technologies, Inc.NWV2026-02-06
00190776415631MillenniumAvalign Technologies, Inc.NWV2026-02-02
00190776415648MillenniumAvalign Technologies, Inc.NWV2026-02-02
00192896122543Probe With EyeSONTEC INSTRUMENTS, INC.FGM2025-11-21
00192896122550Probe With EyeSONTEC INSTRUMENTS, INC.FGM2025-11-21
00198506086489ELMED INCORPORATEDELMED INCORPORATEDNWV2025-11-05
00190776414344MillenniumAvalign Technologies, Inc.NWV2025-10-23
00190776413910MillenniumAvalign Technologies, Inc.NWV2025-10-21
00190776413958MillenniumAvalign Technologies, Inc.NWV2025-10-21
00848657077682AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2025-10-15
00848657077699AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2025-10-15
00848657077705AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2025-10-15
00190776413590MillenniumAvalign Technologies, Inc.NWV2025-10-10
00190776412869MillenniumAvalign Technologies, Inc.NWV2025-10-07