FDA.reportPublic FDA data

Symmetry Surgical®

Primary DI
00887482114834
Brand
Symmetry Surgical®
Company
SYMMETRY SURGICAL INC.
Model
61-0836E
Catalog number
61-0836E
Device description
Symmetry® Speculum, Farrior, Ebonized, Oval Oblique, 6.0 mm x 6.56 mm
Published
2022-09-29
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
EPYSpeculum, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EPYSpeculum, EntGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887482114834PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482114834008874821148348874821148340887482114834

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
Device Size Text, specify0
Device Size Text, specify0

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
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
00840329837457N/ABLACK & BLACK SURGICAL, INC.EPY2026-03-05
G04360200G0GEIZBear-Ent, LLCEPY2026-03-05
G04360201G0GEIZBear-Ent, LLCEPY2026-03-05
G04360202G0GEIZBear-Ent, LLCEPY2026-03-05
G04360203G0GEIZBear-Ent, LLCEPY2026-03-05
G04360204G0GEIZBear-Ent, LLCEPY2026-03-05
00840329837464N/ABLACK & BLACK SURGICAL, INC.EPY2026-03-04
00198506088414ELMED INCORPORATEDELMED INCORPORATEDEPY2026-02-23
00810158218925PRINCETONPrinceton Medical Group, Inc.EPY2026-02-16
00190776415846MillenniumAvalign Technologies, Inc.EPY2026-02-04
G383WM7778700SURJEXSURJEXEPY2026-01-31
G383WM7778701SURJEXSURJEXEPY2026-01-31
G383WM7778702SURJEXSURJEXEPY2026-01-31
G383WM7778703SURJEXSURJEXEPY2026-01-31
04050659354647Brünings anastignatic aural magnifierSpiggle & Theis Medizintechnik GmbHEPY2026-01-21
00810158218437PRINCETONPrinceton Medical Group, Inc.EPY2026-01-07
00810158218444PRINCETONPrinceton Medical Group, Inc.EPY2026-01-07
09348811116314INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-12-02
09348811116321INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-12-02
09348811116352INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-12-02
09348811116376INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-12-02
09348811116390INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-12-02
09348811148865INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-12-02
09348811116574INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-12-01
09348811116628INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-12-01
09348811116772INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-12-01
09348811116789INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-12-01
09348811116895INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-12-01
09348811116901INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-12-01
09348811117083INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-12-01