FDA.reportPublic FDA data

SONTEC PATELLA RASPATORY

Primary DI
00192896094482
Brand
SONTEC PATELLA RASPATORY
Company
SONTEC INSTRUMENTS, INC.
Model
345-247
Catalog number
345-247
Device description
SONTEC PATELLA RASPATORY WITH TUNGSTEN CARBIDE INSERT #4
Published
2019-03-07
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

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
00192896094482PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896094482001928960944821928960944820192896094482

GMDN Terms#

Term, Definition table
TermDefinition
Bone file/rasp, manualA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length7.125Inch

Sterilization Methods#

Method table
Method
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
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00192896015104REEH STITCH SCISSORS13-832513-83252018-09-12
00192896062238RYDER NEEDLE HOLDER2300-3152300-3152018-09-12
00192896105171Small Plates355-236A355-236A2020-10-05
00192896122833Intraocular Set1100-034-SET1100-034-SET2026-03-19
00192896122840Alyea-Babcock Vasectomy Clamp516-695516-6952026-03-19
00192896122857Diamond Head Grasping Forceps1273-1251273-1252026-03-19
00192896122864Velociraptor Junior Rongeur1273-171F1273-171F2026-03-19
00192896122871Spoon Curette2900-2222900-2222026-03-19
00192896122888Dissector2900-2332900-2332026-03-19
00192896122895Ball Dissector2900-2352900-2352026-03-19
00192896122901Hook Dissector2900-2372900-2372026-03-19
00192896122918Hook Dissector2900-2382900-2382026-03-19
00192896122925Spatula Dissector2900-2422900-2422026-03-19
00192896122932Spatula Dissector2900-2442900-2442026-03-19
00192896122949Deluxe Alligator Grasping Forceps1100-333D1100-333D2026-03-19
00192896122680Schroeder Vulsellum Bone Clamp1103-0641103-0642026-03-10
00192896122697Cooley Vascular Clamp2100-527C2100-527C2026-03-10
00192896122703Ochsner Dissector2700-155T2700-155T2026-03-10
00192896122710Debakey Coarctation Clamp2100-6312100-6312026-03-10
00192896122727Debakey Coarctation Clamp2100-6352100-6352026-03-10

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