FDA.report

JACOBSON HOOK

Primary DI
00192896036680
Brand
JACOBSON HOOK
Company
SONTEC INSTRUMENTS, INC.
Model
413-018S
Catalog number
413-018S
Device description
JACOBSON HOOK PROBE BLUNT ANGLED TIP STAINLESS STEEL
Published
2018-09-10
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
GDIDissector, Surgical, General & Plastic Surgery
HXBPROBE

Product Code Classifications

CodeDeviceSpecialtyClass
GDIDissector, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1
HXBProbeOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00192896036680PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896036680001928960366801928960366800192896036680

GMDN Terms

TermDefinition
Bone lever/elevatorA hand-held manual surgical instrument designed to lift, position, or pry up (elevate) bone, other anatomical structures, or surgical material/devices during an orthopaedic intervention. It is made of high-grade stainless steel and is available in a wide variety of sizes, designs, and blade shapes. It is typically a robust instrument with a blunted blade with no cutting edge at the distal end that can be pointed, rounded, flat, curved or hook shaped and a handle of various designs at the proximal end. Some types can have special functions, e.g., for angle joint operations or for luxation procedures. This is a reusable device.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length7.5Inch

Sterilization Methods

Method
Dry Heat Sterilization;Moist Heat or Steam 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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