FDA.reportPublic FDA data

ARTHROSCOPIC SWITCH STICK

Primary DI
00192896056596
Brand
ARTHROSCOPIC SWITCH STICK
Company
SONTEC INSTRUMENTS, INC.
Model
1271-117
Catalog number
1271-117
Device description
ARTHROSCOPIC SWITCH STICK
Published
2018-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896056596PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896056596001928960565961928960565960192896056596

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic dilation guide rodA compact metal rod intended to be used during expansion of a laparoscopic access port (e.g., from 10 to 20 mm) by facilitating: 1) removal of an existing access cannula; and 2) introduction of a dilator/cannula assembly. It is inserted into the existing access cannula, keeping the opening airtight whilst the smaller access cannula is removed; a special dilator assembled with a larger access cannula is fed back over the guide rod. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length8Inch

Sterilization Methods#

Method table
Method
"[""Dry Heat Sterilization"", ""Moist Heat or Steam Sterilization""]"
Dry Heat Sterilization;Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800) 821-7496info@sontecinstruments.com
+1(800)821-7496info@sontecinstruments.com

Regulatory Flags#

DUNS number
040729840
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

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00192896101524BONE TAMP1103-197A1103-197A2020-05-11
00192896099715WILDE ETHMOID RONGEUR468-622468-6222018-09-20
00192896094109ROCHESTER CARMALT FORCEPS1100-153Q1100-153Q2019-03-07
00192896094475ROCHESTER CARMALT FORCEPS1100-152Q1100-152Q2019-03-07

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