FDA.reportPublic FDA data

GERSTEN TRACTION BAR

Primary DI
00192896077331
Brand
GERSTEN TRACTION BAR
Company
SONTEC INSTRUMENTS, INC.
Model
305-505
Catalog number
305-505
Device description
GERSTEN TRACTION BAR
Published
2018-09-20
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
00192896077331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896077331001928960773311928960773310192896077331

GMDN Terms#

Term, Definition table
TermDefinition
Bone clamp traction barA manual surgical device designed to bridge two opposing bone clamps being used as a pair, one on either side of a fracture (the proximal and distal segment of a fractured bone) that is being approximated during orthopaedic surgery. It is attached to the stem of each of the bone clamps and using its screw mechanism, the fracture is drawn together by the surgeon. It is typically made of high-grade stainless steel and is designed for this function only. This is a reusable device.

Sterilization Methods#

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