FDA.report

KURTZ CUTOFF SUCTION ADAPTER

Primary DI
B099412738550
Brand
KURTZ CUTOFF SUCTION ADAPTER
Company
SONTEC INSTRUMENTS, INC.
Model
412-738-55
Device description
KURTZ CUTOFF SUCTION ADAPTER
Published
2018-08-21
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
JOLCatheter And Tip, Suction

Product Code Classifications

CodeDeviceSpecialtyClass
JOLCatheter And Tip, SuctionGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B099412738550PreviousHIBCC0
00192896001152PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896001152001928960011521928960011520192896001152

GMDN Terms

TermDefinition
Surgical power tool adaptorA connecting device designed as a mechanical coupling to join and lock together a distal tool to the surgical power tool to provide the power when these are incompatible and are of a different manufacture/industry standard. It is typically made from high-grade stainless steel and/or synthetic material and is available in a variety of shapes and sizes. This device may be cannulated to allow the use of a guidewire. There are various types such as a Hudson adaptor, Trinkle adaptor, Zimmer adaptor. This is a reusable device.

Device Sizes

TypeValueUnit
Length2.2Inch

Sterilization Methods

Method
Dry Heat Sterilization;Moist Heat or Steam Sterilization

Contacts

PhoneEmail
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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