FDA.reportPublic FDA data

NA

Primary DI
04055207045121
Brand
NA
Company
Richard Wolf GmbH
Model
8991017
Catalog number
8991.017
Device description
OBTURATOR FOR VAGINOSCOPE OD 14.8MM for WL 200mm, compatible with amniotic scope tube 8991015, reusable
Published
2016-09-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HEZENDOSCOPE, TRANSCERVICAL (AMNIOSCOPE)(AND ACCESSORIES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HEZEndoscope, Transcervical (Amnioscope)(And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04055207045121PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055207045121040552070451214055207045121

GMDN Terms#

Term, Definition table
TermDefinition
Rigid endoscope obturatorAn endoscopic device that is a component of a rigid endoscope assembly that has a distally rounded, solid, head or end that is placed into the sheath of a rigid endoscope in order to fill out the sheath's lumen (open end), thereby assisting its insertion into the body and protecting against damage to the patient. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter14.8Millimeter

Sterilization Methods#

Method table
Method
"[""Hydrogen Peroxide"", ""Moist Heat or Steam Sterilization"", ""Ethylene Oxide""]"
Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04055207045053NARichard Wolf GmbHHEZ2016-09-28
04055207045060NARichard Wolf GmbHHEZ2016-09-28
04055207045077NARichard Wolf GmbHHEZ2016-09-28
04055207045084NARichard Wolf GmbHHEZ2016-09-28
04055207045091NARichard Wolf GmbHHEZ2016-09-28
04055207045107NARichard Wolf GmbHHEZ2016-09-28
04055207045114NARichard Wolf GmbHHEZ2016-09-28
04055207045138NARichard Wolf GmbHHEZ2016-09-28
04055207045145NARichard Wolf GmbHHEZ2016-09-28