FDA.report

NA

Primary DI
04055207048757
Brand
NA
Company
Richard Wolf GmbH
Model
4712348
Catalog number
4712348
Device description
UNIVERSAL SEALING VALVE 1-6FR for introducing instruments from 1-6Fr, PACK=5 PCS, sterile, 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
FAJCystoscope and accessories, flexible/rigid

Product Code Classifications

CodeDeviceSpecialtyClass
FAJCystoscope And Accessories, Flexible/RigidGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04055207048757PrimaryGS10
04055207049396Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04055207048757040552070487574055207048757
04055207049396040552070493964055207049396

GMDN Terms

TermDefinition
Endoscopic biopsy valve, sterileA sterile device intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of biomaterial during an endoscopic procedure. It is typically in the form of a small attachment with an elastomer seal; it may include a water input valve for simultaneous irrigation/biopsy. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Humidity35 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+497043350info@richard-wolf.com

Regulatory Flags

DUNS number
315304071
Device count
5
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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