FDA.report

NA

Primary DI
04055207039151
Brand
NA
Company
Richard Wolf GmbH
Model
826714
Catalog number
8267.14
Device description
KNIFE TL 262MM straight, oval, reusable
Published
2022-08-09
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
JZYKNIFE, LARYNGEAL

Product Code Classifications

CodeDeviceSpecialtyClass
JZYKnife, LaryngealEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04055207039151PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04055207039151040552070391514055207039151

GMDN Terms

TermDefinition
Tonsil knifeA hand-held manual surgical instrument intended for the removal of the tonsils during a surgical intervention. It is typically designed as a one-piece instrument with a sharp, single-edged, scythe-like, cutting blade at the distal end (the internal radius of the curve has the cutting edge) which is normally quite small; it has a very long and slender shaft with a handle at the proximal end. It is normally made of high-grade stainless steel. This is a reusable device.

Device Sizes

TypeValueUnit
Length262Millimeter

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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