FDA.reportPublic FDA data

Symmetry Boucheron

Primary DI
00887482145845
Brand
Symmetry Boucheron
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
61-0905
Catalog number
61-0905
Device description
Symmetry® Speculum, Boucheron, Chrome Plated, Round, Large, 5.5 mm To 9.0 mm, (4/st)
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
EPYSpeculum, Ent

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887482145845PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482145845008874821458458874821458450887482145845

GMDN Terms#

Term, Definition table
TermDefinition
Gelfoam punchA manual instrument designed to punch circles of various sizes from a piece of Gelfoam (a sterile compressed gelatin sponge having haemostatic properties which usually absorbs completely within four to six weeks) typically used to help construct ossicular replacements during middle ear surgery. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Circumference5.5Millimeter
Circumference9Millimeter

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
00887482049938Symmetry Surgical55-868055-86802018-09-25
00887482049945Symmetry Surgical55-868155-86812018-09-25
00887482049952Symmetry Surgical55-868255-86822018-09-25
00887482049969Symmetry Surgical55-868355-86832018-09-25
00887482090282Symmetry Surgical55-868455-86842018-09-25
00887482090299Symmetry Surgical55-868555-86852018-09-25
00840113235445Bovie Fluoro-Dot68022026-10-21
00840113233915RN-Pack66RN2026-10-20
00840113233939High Intensity Medical Penlights Disposable66662026-10-20
00840113235438Diagnostic Medical Penlights63032026-10-20
00840113236367BovieUV592026-10-20
00887482156667Symmetry53-1675RC2026-09-29
10840113232908BovieAA002026-09-21
10840113232922BovieAA00X2026-09-21
10840113232946BovieAA012026-09-21
10840113232960BovieAA01X2026-09-21
10840113232984BovieAA022026-09-21
10840113233004BovieAA032026-09-21
10840113233028BovieAA03X2026-09-21
10840113233042BovieAA042026-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250676750662Farrior ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750679Farrior ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750686Farrior ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750693Farrior ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750709Farrior ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750716Farrior ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750723Farrior ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750730Farrior ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750761Hartmann ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750778Hartmann ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750785Hartmann ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750792Hartmann ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750808Hartmann ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750945Tieck-Halle nasal speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750952Tieck-Halle nasal speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750969Vienna model nasal speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750976Hartmann-Halle nasal speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750983Hartmann-Halle nasal speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750990Hartmann-Halle nasal speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676751003Killian septum speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676751010Killian septum speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676751027Killian septum speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676751041Le Mee ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676751058Le Mee ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676751065Le Mee ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676751072Le Mee ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676751089Le Mee ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676751096Le Mee ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676751102Farrior ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676751119Farrior ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28