FDA.report

NA

Primary DI
04055207007372
Brand
NA
Company
Richard Wolf GmbH
Model
4171111
Catalog number
4171.111
Device description
HYGIENE-FILTER for single use
Published
2017-06-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
HIFINSUFFLATOR, LAPAROSCOPIC

Product Code Classifications

CodeDeviceSpecialtyClass
HIFInsufflator, LaparoscopicObstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04055207007372PrimaryGS10
04055207049891Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04055207007372040552070073724055207007372
04055207049891040552070498914055207049891

GMDN Terms

TermDefinition
Microbial medical gas filter, sterile, single-useA sterile screening device intended to remove microbes from medical gases to prevent patient exposure during respiration, anaesthesia, and/or surgical intervention (e.g., insufflation); it has no additional non-filtering intended uses. It is a small plastic housing containing a filter which will typically also filter other particulates (e.g., scale). This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+497043350info@richard-wolf.com

Regulatory Flags

DUNS number
315304071
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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