FDA.reportPublic FDA data

Symmetry House

Primary DI
00887482113974
Brand
Symmetry House
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
61-0390
Catalog number
61-0390
Device description
Symmetry® Mirror, House Middle Ear, Angled 45° on Straight Shaft, 2.5 mm Mirrors, 6 1/2 in
Published
2024-08-12
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
FTXMirror, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTXMirror, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887482113974PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482113974008874821139748874821139740887482113974

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgery mirrorA reflective device designed to be used to assist practitioners during general/plastic surgery by displaying the image of an object placed before it.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle45degree
Device Size Text, specify0
Length6.5Inch

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
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

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Primary DI, Brand, Company table
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D9436968Power Dental USAPower Dental U.S.A. Inc.FTX2022-01-12
D943N6968Power Dental USAPower Dental U.S.A. Inc.FTX2022-01-12
D9436950S0Power Dental USAPower Dental U.S.A. Inc.FTX2022-01-08
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00190776044268AvalignAvalign Technologies, Inc.FTX2021-11-03
D943N6952Power Dental U.S.A., Inc.Power Dental U.S.A. Inc.FTX2021-07-17
D943193010Power Dental USAPower Dental U.S.A. Inc.FTX2021-07-13
D9436920BE0Power Dental USAPower Dental U.S.A. Inc.FTX2021-07-13
D94369710Power Dental USAPower Dental U.S.A. Inc.FTX2021-07-13
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