FDA.reportPublic FDA data

NA

Primary DI
04055207038659
Brand
NA
Company
Richard Wolf GmbH
Model
89101
Catalog number
89.101
Device description
SEAL Ø 7.5MM silicone seal, yellow, for instruments 1-5mm, Length 2mm, reusable
Published
2016-09-28
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
FGAKit, nephroscope
GCHMEDIASTINOSCOPE, DIAGNOSTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGAKit, NephroscopeGastroenterology, Urology2
GCHMediastinoscope, DiagnosticGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04055207038659PrimaryGS10
04055207059616Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055207038659040552070386594055207038659
04055207059616040552070596164055207059616

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Outer Diameter7.5Millimeter

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
10
DM 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
04055207066805NA880888.082026-06-02
04055207007709NA180118.012026-05-29
04055207007723RIWO880388.032026-05-29
04055207007747NA890089.002026-05-29
04055207007792NA890589.052026-05-29
04055207007815NA890989.092026-05-29
04055207007839NA892089.202026-05-29
04055207008409NA8917189.1712026-05-29
04055207038505RIWO880088.002026-05-29
04055207038529RIWO880288.022026-05-29
04055207038536RIWO880488.042026-05-29
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

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06925816657665ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
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06925816657740ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
00810143891294Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FGA2025-04-25
04055207038666NARichard Wolf GmbHFGA2024-04-01