NA

Primary DI
04055207045114
Brand
NA
Company
Richard Wolf GmbH
Model
8991015
Catalog number
8991.015
Device description
AMNIOSCOPE TUBE ID 14.8MM OD 18/42MM for adults, TL 222mm, distal end straight, graduated, 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
04055207045114PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055207045114040552070451144055207045114

GMDN Terms#

Term, Definition table
TermDefinition
Transcervical amnioscopeAn endoscope with a rigid inserted portion intended for the visual examination of the foetus while in the amnion (the thin, tough membrane that lines the chorion and contains the foetus and the amniotic fluid). It is inserted via the vagina, through the maternal uterine cervix and into the amniotic cavity. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. This device is typically used to examine the foetus for external malformations, to obtain foetal blood or tissue samples, and for the observation of the colour and volume of amniotic fluid. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter14.8Millimeter

Sterilization Methods#

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

Contacts#

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

Regulatory Flags#

DUNS number
315304071
Device count
1
DM exempt
true
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
04055207045121NARichard Wolf GmbHHEZ2016-09-28
04055207045138NARichard Wolf GmbHHEZ2016-09-28
04055207045145NARichard Wolf GmbHHEZ2016-09-28