FDA.reportPublic FDA data

Symmetry Surgical®

Primary DI
00887482053300
Brand
Symmetry Surgical®
Company
SYMMETRY SURGICAL INC.
Model
09-5229
Catalog number
09-5229
Device description
Symmetry® Trocar, Sinoscopy, And Cannula, 5.0 mm
Published
2024-08-15
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
KTETrocar, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTETrocar, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887482053300PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482053300008874820533008874820533000887482053300

GMDN Terms#

Term, Definition table
TermDefinition
ENT trocar bladeA rigid, surgical instrument with a sharp pyramidal or conical point used to puncture body cavities during ear/nose/throat (ENT) surgery. It can be assembled and used together with a compatible cannula (not included) filling its lumen, thereby allowing the introduction of this assembly; following puncture, the trocar blade is withdrawn. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-888-364-7004customerservice@symmetrysurgical.com
+1 888-364-7004customerservice@symmetrysurgical.com

Regulatory Flags#

DUNS number
079641356
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887482196533Symmetry Barraquer60-1906-SYM60-1906-SYM2025-07-24
00887482196540Symmetry Castroviejo60-1910-SYM60-1910-SYM2025-07-24
00887482012307Symmetry Tyrell 38-652538-65252022-09-16
00887482006559Symmetry Surgical32-348532-34852024-09-05
00887482006566Symmetry Surgical32-348532-34852024-09-05
00887482196793Symmetry Surgical90-1042R90-1042R2024-09-05
00887482030578Symmetry Hardy80-133080-13302024-09-05
00887482030585Symmetry Hardy80-133180-13312024-09-05
00887482030592Symmetry Hardy80-133280-13322024-09-05
00887482030608Symmetry Hardy80-133380-13332024-09-05
00887482030615Symmetry Hardy80-133480-13342024-09-05
00887482030622Symmetry Hardy80-133580-13352024-09-05
00887482030707Symmetry Hardy80-134580-13452024-09-05
00887482030714Symmetry Hardy80-134680-13462024-09-05
00887482030721Symmetry Hardy80-134780-13472024-09-05
00887482030738Symmetry Hardy80-134880-13482024-09-05
00887482031124Symmetry Verity™80-153680-15362024-09-05
00887482031506Symmetry Rhoton®80-169280-16922024-09-05
00887482031513Symmetry Rhoton®80-169380-16932024-09-05
00887482116203Symmetry Paparella61-377561-37752024-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04046826472153MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKTE2025-12-17
00757770422029Bausch + LombBausch & Lomb IncorporatedKTE2024-11-21
10381780538530MicroFrance®INTEGRA MICROFRANCEKTE2024-05-29
00381780105872MicroFrance®INTEGRA MICROFRANCEKTE2024-05-29
24026704912050PILLINGTELEFLEX INCORPORATEDKTE2024-05-24
00888515242265BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KTE2024-02-28
00888515242272BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KTE2024-02-28
00888515243262BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KTE2024-02-28
00888515243279BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KTE2024-02-28
G586E1063390Novo SurgicalNOVO SURGICAL, INC.KTE2023-12-18
07899893232154NEONAILNeoortho Produtos Ortopédicos S/A.KTE2023-11-29
00190776378455MillenniumAvalign Technologies, Inc.KTE2023-11-13
00190776322687MILLENNIUMAvalign Technologies, Inc.KTE2023-09-28
00190776375201MILLENNIUMAvalign Technologies, Inc.KTE2023-09-28
54026704809276PILLINGTELEFLEX INCORPORATEDKTE2022-12-08
00842331163500Novo Surgical Inc. NOVO SURGICAL, INC.KTE2022-11-13
14026704730886PILLINGTELEFLEX INCORPORATEDKTE2022-04-27
00190776046545AvalignAVALIGN TECHNOLOGIES, INC.KTE2021-11-03
00190660192389Ambler SurgicalAMBLER SURGICAL CORP.KTE2021-01-04
00190660192396Ambler SurgicalAMBLER SURGICAL CORP.KTE2021-01-04
00190660192402Ambler SurgicalAMBLER SURGICAL CORP.KTE2021-01-04
00190660192419Ambler SurgicalAMBLER SURGICAL CORP.KTE2021-01-04
00190660192426Ambler SurgicalAMBLER SURGICAL CORP.KTE2021-01-04
00190660192600Ambler SurgicalAMBLER SURGICAL CORP.KTE2021-01-04
00190660192617Ambler SurgicalAMBLER SURGICAL CORP.KTE2021-01-04
00190660192624Ambler SurgicalAMBLER SURGICAL CORP.KTE2021-01-04
00190660192631Ambler SurgicalAMBLER SURGICAL CORP.KTE2021-01-04
00190660192648Ambler SurgicalAMBLER SURGICAL CORP.KTE2021-01-04
00190660211158Ambler SurgicalAMBLER SURGICAL CORP.KTE2021-01-04
00190660211165Ambler SurgicalAMBLER SURGICAL CORP.KTE2021-01-04