FDA.reportPublic FDA data

UNIQUE PERIOSTEAL ELEVATOR

Primary DI
00192896052796
Brand
UNIQUE PERIOSTEAL ELEVATOR
Company
SONTEC INSTRUMENTS, INC.
Model
1103-326B
Catalog number
1103-326B
Device description
UNIQUE PERIOSTEAL ELEVATOR DOUBLE ENDED TIPS EX-8
Published
2018-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EMJELEVATOR, SURGICAL, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMJElevator, Surgical, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896052796PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896052796001928960527961928960527960192896052796

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 (e.g., dental, orthopaedic), including use on the ribs. In dentistry it may be used to access retained roots, or for their removal 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
Length7Inch

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00192896012639ALGERBRUSH DIAMOND BURR11-461011-46102018-09-18
00192896012646ALGERBRUSH DIAMOND FINE GRIT BURR11-461111-46112018-09-18
00192896012653ALGERBRUSH DIAMOND BURR11-461211-46122018-09-18
00192896012660ALGERBRUSH DIAMOND BURR11-461311-46132018-09-18
00192896012677ALGERBRUSH DIAMOND BURR11-461411-46142018-09-18
00192896072398ALGERBRUSH DIAMOND BURR11-460911-46092018-09-19
00192896092792UNIVERSITY OF MINNESOTA CHEEK RETRACTOR207-210207-2102019-01-03
00192896044661BARR PROBE508-547508-5472018-09-14
00192896123397Smithwick Vasectomy Hook516-716516-7162026-05-12
00192896123373Skinner Tissue Forceps140-376H140-376H2026-05-11
00192896123380Biopsy Punch2901-117L2901-117L2026-05-11
00192896123403Mictec High Frequency Cable26944-3226944-322026-05-11
00192896123410Biopsy Cup2901-125L2901-125L2026-05-11
00192896112193HU Capsular Polisher12-268512-26852022-02-03
00192896025929MEYERDING RETRACTOR207-411207-4112018-09-12
00192896025936MEYERDING RETRACTOR207-413207-4132018-09-12
00192896025943MEYERDING RETRACTOR207-415207-4152018-09-12
00192896100671TEALES GORGET SPECULUM516-506516-5062025-02-24
00192896118003Reynolds Tenotomy Scissors2405-329B2405-329B2024-06-21
00192896115750Teales Gorget SpeculumT516-507T516-5072023-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB7540TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7550TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7560TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7570TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7580TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7590TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7600TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7610TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7620TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7630TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7640TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7650TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7660TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7670TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7680TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7690TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7700TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7710TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7830TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7840TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7850TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149NP380810NPSACME ENTERPRISE.EMJ2026-05-01
G149NPPMH0NPSACME ENTERPRISE.EMJ2026-05-01
08961104674998Lux-PerioMELPEX BEAUTY INSTRUMENTSEMJ2026-04-27
08961104675001Lux-PerioMELPEX BEAUTY INSTRUMENTSEMJ2026-04-27
08961104675018Lux-PerioMELPEX BEAUTY INSTRUMENTSEMJ2026-04-27
08961104675025LuxatorMELPEX BEAUTY INSTRUMENTSEMJ2026-04-27
08961104675032LuxatorMELPEX BEAUTY INSTRUMENTSEMJ2026-04-27
08961104675049LuxatorMELPEX BEAUTY INSTRUMENTSEMJ2026-04-27
08961104675056LuxatorMELPEX BEAUTY INSTRUMENTSEMJ2026-04-27