FDA.report

NA

Primary DI
04055207017449
Brand
NA
Company
Richard Wolf GmbH
Model
8457011
Catalog number
8457.011
Device description
OP-LARYNGOSCOPE WL 148MM by Pototschnig adjustable, dilation prox. min. / max. 32x12.5/ 32x27.5mm, dilation dist. min. / max. 16x13.5/ 16x53mm, TL 200mm, straight blade, with contusion protection of soft tissue, outer light carrier and insufflation-suction tube, with universal handle for all support and mounting systems, reusable
Published
2022-02-11
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
CCWLARYNGOSCOPE, RIGID

Product Code Classifications

CodeDeviceSpecialtyClass
CCWLaryngoscope, RigidAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04055207017449PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04055207017449040552070174494055207017449

GMDN Terms

TermDefinition
Rigid intubation laryngoscope, reusableA hand-held device intended to be used by anaesthesia/emergency service personnel to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation. It has a handle containing batteries to power its light (a small built-in light bulb or fibreoptic light) for airway illumination, and a curved or straight blade of various designs and lengths that can be hinged/interchanged or integral. Some types can be magnetic resonance imaging (MRI) compatible. This is a reusable device.

Device Sizes

TypeValueUnit
Length148Millimeter

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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