FDA.report

NA

Primary DI
04055207040027
Brand
NA
Company
Richard Wolf GmbH
Model
837891
Catalog number
8378.91
Device description
PORTIO CONE ATTACHMENT SZ LARGE for introduction of fluid for hysterosalpingography, curved upwards, compatible with intrauterine probe 8378001, with Luer connection, reusable
Published
2022-10-27
Public version status
New
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
HHISystem, abortion, vacuum

Product Code Classifications

CodeDeviceSpecialtyClass
HHISystem, Abortion, VacuumObstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04055207040027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04055207040027040552070400274055207040027

GMDN Terms

TermDefinition
Uterine probeA hand-held manual surgical instrument designed as a slender rod made of metal with an atraumatic tip, intended for exploring the uterus during a surgical procedure. It is typically intended to be used as a component of a uterine manipulator and as such may have a suction channel for applying a vacuum to fixate the manipulator assembly to the uterus; it may include graduated markings. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+497043350info@richard-wolf.com

Regulatory Flags

DUNS number
315304071
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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04055207036693POWER STICK M5/0899550000189955000012025-12-18
04055207000328NA20301052030.1052023-01-11
04055207067987VERTEBRIS8922012788922012782025-11-17
04055207067994VERTEBRIS8922020078922020072025-11-17
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