FDA.reportPublic FDA data

Frazier Dorsey Dura Separator

Primary DI
00192896112353
Brand
Frazier Dorsey Dura Separator
Company
SONTEC INSTRUMENTS, INC.
Model
412-488
Device description
Frazier Dorsey Dura Separator 5 X 15 Millimeter Blade
Published
2022-02-23
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
HTEELEVATOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTEElevatorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896112353PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896112353001928961123531928961123530192896112353

GMDN Terms#

Term, Definition table
TermDefinition
Periosteal elevator, reusableA hand-held manual surgical instrument designed to lift/separate (elevate) or tunnel under the periosteum during surgery, typically orthopaedic, including use on the ribs. It may in addition be used in dentistry to access retained roots, or to remove them with surrounding bone. It is typically a one-piece instrument available in a variety of sizes and blade designs, including straight and curved blades, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length6Inch

Sterilization Methods#

Method table
Method
Dry Heat Sterilization;Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885862659507N/AExactech, Inc.HTE2026-03-19
10885862661364NovationExactech, Inc.HTE2026-03-19
M93072015102SF20Life InstrumentsLife Instrument CorporationHTE2026-03-06
M93072015342S20Life InstrumentsLife Instrument CorporationHTE2026-03-06
M93072015342SF20Life InstrumentsLife Instrument CorporationHTE2026-03-06
00840277133373Innomed, Inc.INNOMED, INC.HTE2026-02-26
00840277133380Innomed, Inc.INNOMED, INC.HTE2026-02-26
00190776416539MillenniumAvalign Technologies, Inc.HTE2026-02-16
03662663109468Mergence-A Preparation InstrumentationHighridge Medical, LLCHTE2026-02-11
00190376539003Intervertebral Disc Preparation InstrumentsALPHATEC SPINE, INC.HTE2026-02-10
M93072513543B0Life Instruments Life Instrument CorporationHTE2026-02-02
00840180545096General InstrumentsALPHATEC SPINE, INC.HTE2026-01-29
00840180545102General InstrumentsALPHATEC SPINE, INC.HTE2026-01-29
00840180545119General InstrumentsALPHATEC SPINE, INC.HTE2026-01-29
00840277133151Innomed, Inc.INNOMED, INC.HTE2026-01-16
00840180543313General InstrumentsALPHATEC SPINE, INC.HTE2025-12-31
00840180543320General InstrumentsALPHATEC SPINE, INC.HTE2025-12-31
00840180543337General InstrumentsALPHATEC SPINE, INC.HTE2025-12-31
00840180543344General InstrumentsALPHATEC SPINE, INC.HTE2025-12-31
00840180543351General InstrumentsALPHATEC SPINE, INC.HTE2025-12-31
00840180543368General InstrumentsALPHATEC SPINE, INC.HTE2025-12-31
03662663156905SOLITAIRE CERVICAL SPACER SYSTEMHighridge Medical, LLCHTE2025-12-29
00199150051687Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTE2025-12-25
00199150051694Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTE2025-12-25
00199150051700Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTE2025-12-25
03662663272186Timberline Lateral Fusion SystemHighridge Medical, LLCHTE2025-12-18
03662663272193Timberline Lateral Fusion SystemHighridge Medical, LLCHTE2025-12-18
03662663272209Timberline Lateral Fusion SystemHighridge Medical, LLCHTE2025-12-18
03662663272216Timberline Lateral Fusion SystemHighridge Medical, LLCHTE2025-12-18
03662663272223Timberline Lateral Fusion SystemHighridge Medical, LLCHTE2025-12-18