FDA.report

COTTLE CARTILAGE CRUSHER

Primary DI
00192896032002
Brand
COTTLE CARTILAGE CRUSHER
Company
SONTEC INSTRUMENTS, INC.
Model
350-844
Catalog number
350-844
Device description
COTTLE CARTILAGE CRUSHER DOUBLE SIDED
Published
2018-09-17
Public version status
New
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
HWNINSTRUMENT, COMPRESSION

Product Code Classifications

CodeDeviceSpecialtyClass
HWNInstrument, CompressionOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00192896032002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896032002001928960320021928960320020192896032002

GMDN Terms

TermDefinition
Surgical material compression deviceA manual device designed to flatten material (e.g., tissue, foam) for use in a surgical procedure (e.g., tympanoplasty) after it has been flattened. The device is typically in the form of two hinged plates with a tightening mechanism (e.g., screws) to press the plates together with the material between. It is typically made of high-grade stainless steel. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization;Dry Heat Sterilization

Contacts

PhoneEmail
+1(800) 821-7496info@sontecinstruments.com

Regulatory Flags

DUNS number
040729840
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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