FDA.report

CANNULA IRRIGATION SET

Primary DI
00192896089600
Brand
CANNULA IRRIGATION SET
Company
SONTEC INSTRUMENTS, INC.
Model
SC95-0315-SET
Catalog number
SC95-0315-SET
Device description
CANNULA IRRIGATION SET WITH STOP COCKSET AND SHARP/BLUNT OBTURATOR
Published
2019-05-10
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
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00192896089600PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896089600001928960896001928960896000192896089600

GMDN Terms

TermDefinition
Surgical drill guide obturatorA surgical device designed to fill the lumen of a drill guide during its insertion to a surgical site primarily to prevent tissue obstruction of the drill guide lumen. When the drill guide is firmly placed at the chosen position on the bone surface, the obturator is removed. It is typically a rod with a rounded distal end, which protrudes out of the drill guide, and a knob-like handle that functions as a regulator to control the length of the protruding end and to remove it from the drill guide. It is typically made of a high-grade stainless steel. This is a reusable device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method
Moist Heat or Steam Sterilization;Dry Heat 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
true
Sterilization required before use
true

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