FDA.report

n.a.

Primary DI
04048551267523
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
28164ERS
Catalog number
28164ERS
Device description
Micro Raspatory, 2 mm, length 25 cm
Published
2018-09-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GZXINSTRUMENT, MICROSURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
GZXInstrument, MicrosurgicalNeurology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048551267523PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048551267523040485512675234048551267523

GMDN Terms

TermDefinition
Cartilage knifeA hand-held manual surgical instrument designed for cutting, shaving or shaping cartilage during a surgical intervention. It is typically a one-piece instrument with a sharp, single-edged, cutting blade at the distal end which is normally very long, similar in shape to a scalpel blade, and may vary in length and size; it has a handle at the proximal end. It is normally made of high-grade stainless steel. Also known as a chondrotome, a cartilage knife can also be used in pathology procedures. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+14242188201regulatory@karlstorz.com

Regulatory Flags

DUNS number
315731430
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
false
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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