FDA.reportPublic FDA data

Symmetry Surgical

Primary DI
00887482053300
Brand
Symmetry Surgical
Company
ASPEN SURGICAL PRODUCTS, 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
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
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filling its lumen, thereby allowing the introduction of this assembly; following puncture, the trocar blade is withdrawn.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
027680821
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841785102714Symmetry Olsen20-1040I20-1040I2016-09-09
00841785102769Symmetry Olsen20-106020-10602016-09-06
00841785102776Symmetry Olsen20-1060I20-1060I2016-09-06
00841785102899Symmetry Olsen20-108020-10802016-09-06
00841785102905Symmetry Olsen20-1080I20-1080I2016-09-06
00841785102950Symmetry Olsen20-108220-10822016-09-06
00841785102967Symmetry Olsen20-1082I20-1082I2016-09-06
00841785102974Symmetry Olsen20-1082IMT20-1082IMT2016-09-07
00841785103025Symmetry Olsen20-109020-10902016-09-06
00841785103032Symmetry Olsen20-1090I20-1090I2016-09-06
00841785103049Symmetry Olsen20-1090IMT20-1090IMT2016-09-07
00841785103162Symmetry Olsen20-1162I20-1162I2016-09-06
00841785103285Symmetry Olsen20-1190I20-1190I2016-09-06
00841785103667Symmetry Olsen20-1325I20-1325I2016-09-08
00841785103674Symmetry Olsen20-1325IMT20-1325IMT2016-09-08
00841785103735Symmetry Olsen20-1330I20-1330I2016-09-08
00841785103742Symmetry Olsen20-1330IMT20-1330IMT2016-09-09
00841785103803Symmetry Olsen20-1340I20-1340I2016-09-06
00841785103865Symmetry Olsen20-1350I20-1350I2016-09-06
00841785103988Symmetry Olsen20-1360I20-1360I2016-09-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05055445930615SurtexSURTEX INSTRUMENTS LTD.KTE2026-05-12
05055445930622SurtexSURTEX INSTRUMENTS LTD.KTE2026-05-12
05055445930639SurtexSURTEX INSTRUMENTS LTD.KTE2026-05-12
05055445930646SurtexSURTEX INSTRUMENTS LTD.KTE2026-05-12
05055445930653SurtexSURTEX INSTRUMENTS LTD.KTE2026-05-12
05055445930660SurtexSURTEX INSTRUMENTS LTD.KTE2026-05-12
04046826472153MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKTE2025-12-17
04250381812860Antrum trocar, oblique beakSpiggle & Theis Medizintechnik GmbHKTE2025-10-05
04250381812846Antrum trocar, beakedSpiggle & Theis Medizintechnik GmbHKTE2025-09-10
04250381812853Antrum trocar, oblique beakSpiggle & Theis Medizintechnik GmbHKTE2025-09-10
04250381812877Antrum trocar, oblique beakSpiggle & Theis Medizintechnik GmbHKTE2025-09-10
00757770422029Bausch + LombBausch & Lomb IncorporatedKTE2024-11-21
10381780540120MicroFrance®INTEGRA MICROFRANCEKTE2024-05-29
10381780538530MicroFrance®INTEGRA MICROFRANCEKTE2024-05-29
00381780105872MicroFrance®INTEGRA MICROFRANCEKTE2024-05-29
14026704912053PILLINGTELEFLEX INCORPORATEDKTE2024-05-24
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
14026704809278PILLINGTELEFLEX INCORPORATEDKTE2022-12-08
54026704809276PILLINGTELEFLEX INCORPORATEDKTE2022-12-08
00842331163500Novo Surgical Inc. NOVO SURGICAL, INC.KTE2022-11-13
14026704730886PILLINGTELEFLEX INCORPORATEDKTE2022-04-27