FDA.reportPublic FDA data

Symmetry Shea

Primary DI
00887482116463
Brand
Symmetry Shea
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
62-0380
Catalog number
62-0380
Device description
Symmetry® Speculum, Shea Ear Holder, 11 3/4 in, 298 mm
Published
2022-09-29
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
FXGSpecula Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXGSpecula AccessoriesGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887482116463PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482116463008874821164638874821164630887482116463

GMDN Terms#

Term, Definition table
TermDefinition
Ear speculum, reusableA rigid plastic or metal tube that is cone-shaped (i.e., it tapers down from a standard instrument fitting size to a small opening) and is either hand-held and manually inserted, or fitted onto a compatible otoscope, and then inserted into the ear canal to create a channel for examination, suction, irrigation, or the insertion of another surgical device during an ear/nose/throat (ENT) procedure. It may in addition be intended for use with an audiometer and might also be referred to as an ear cannula or probe. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length11.75Inch

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+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
00840113234356BovieA1204C2026-08-17
10840113234728Bovie00032026-08-17
10840113237705BovieESP62026-08-17
10840113237712BovieESP1HN2026-08-17
10840113242426Bovie00022026-08-17
10840113244635Bovie00012026-08-17
10607151008328BovieBVX-LL06T-NSBVX-LL06T-NS2016-09-13
10607151008335BovieBVX-LC04T-NSBVX-LC04T-NS2016-09-13
10607151008342BovieBVX-LB02T-NSBVX-LB02T-NS2016-09-13
10607151008366BovieBVX-LJ07T-NSBVX-LJ07T-NS2016-09-13
10607151008373BovieBVX-LH08T-NSBVX-LH08T-NS2016-09-13
10607151008380BovieBVX-LH01T-NSBVX-LH01T-NS2016-09-13
10607151008397BovieBVX-LN03T-NSBVX-LN03T-NS2016-09-13
10607151011267BovieCS-103T-SDVCS-103T-SDV2016-08-29
10607151011281BovieCS-103T-SVCS-103T-SV2016-08-29
10607151011304BovieCS103T-SVMCS103T-SVM2016-08-29
10607151011311BovieCS-105LEDCS-105LED2016-08-29
10607151011328BovieCS-105T-LEDCS-105T-LED2016-08-29
10607151009905BovieE15626E156262020-11-16
00607151009076BovieLS05LS052016-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04030155000644Ear funnel, grey, small, Ø 2,5 mm, PU = 1000 pcs.Kirchner & Wilhelm GmbH + Co KGFXG2026-06-25
04030155000675Ear funnel, grey, large, Ø 4,0 mm, PU = 1000 pcs.Kirchner & Wilhelm GmbH + Co KGFXG2026-06-25
00850071684308REALSTAR SURGICAL INSTRUMENTSREAL STAR SURGICAL INSTRUMENTSFXG2025-09-09
04030155000774Reusable ear funnels Ø 4.0 mm, 10 pcs.Kirchner & Wilhelm GmbH + Co KGFXG2024-07-24
00840183503987BR Surgical, LLCBR Surgical, LLCFXG2024-02-06
00190776317799MillenniumAvalign Technologies, Inc.FXG2023-11-13
04030155000613Ear funnel, black, small Ø 2.5 mm, in units of 100 pcs.Kirchner & Wilhelm GmbH + Co KGFXG2023-08-30
04030155000637Ear funnel, black, large Ø 4.0 mm, in units of 100 pcs.Kirchner & Wilhelm GmbH + Co KGFXG2023-08-30
04030155000651Ear funnel, grey, small Ø 2.5 mm, 10 x 100 pcs. in polybagKirchner & Wilhelm GmbH + Co KGFXG2023-08-30
04030155000668Ear funnel, small, grey, Ø 2.5 mm, 10 x 100 pcs. in cartonKirchner & Wilhelm GmbH + Co KGFXG2023-08-30
04030155000682Ear funnel, grey, large Ø 4.0 mm, 10x100 pcs. in polybagKirchner & Wilhelm GmbH + Co KGFXG2023-08-30
04030155000699Ear funnel, large, grey, Ø 4.0 mm, 10 x 100 pcs. in cartonKirchner & Wilhelm GmbH + Co KGFXG2023-08-30
00190776042479AvalignAvalign Technologies, Inc.FXG2023-06-23
00840183506872BR Surgical, LLCBR Surgical, LLCFXG2023-05-15
00840183510725BR Surgical, LLCBR Surgical, LLCFXG2023-05-15
14026704806307PILLINGTELEFLEX INCORPORATEDFXG2022-12-08
54026704806305PILLINGTELEFLEX INCORPORATEDFXG2022-12-08
00842331151125Novo Surgical Inc. NOVO SURGICAL, INC.FXG2022-11-12
27290018446120N9 speculumNONAGON LTDFXG2021-09-13
07290018446126N9 speculumNONAGON LTDFXG2021-09-13
10812594011853Neotech Ocular Exam KitNeotech Products LLCFXG2021-06-14
10812594012485Neonatal Ocular Exam Kit 2-packNeotech Products LLCFXG2021-06-14
10812594012492Neotech Ocular Exam KitNeotech Products LLCFXG2021-06-14
10812594012508Ocular Exam DepressorNeotech Products LLCFXG2021-06-14
10812594012515Ocular Exam Neonatal SpeculumNeotech Products LLCFXG2021-06-14
10812594012522Ocular Exam Standard SpeculumNeotech Products LLCFXG2021-06-14
00812594011856Ocular Exam Kit NeonatalNEOTECH PRODUCTS, INC.FXG2021-06-14
00812594012488Neonatal Ocular Exam Kit 2-packNEOTECH PRODUCTS, INC.FXG2021-06-14
00812594012495Ocular Exam Kit StandardNEOTECH PRODUCTS, INC.FXG2021-06-14
00812594012501Ocular Exam DepressorNEOTECH PRODUCTS, INC.FXG2021-06-14