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
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00840113233328BovieH101-ADH2026-09-04
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00840113233366BovieH1042026-09-04
00840113233380BovieH1052026-09-04
00840113233403BovieH1062026-09-04
00840113233427BovieH1092026-09-04
00840113233441BovieH1102026-09-04
00840113233465BovieH1112026-09-04
00840113233489BovieH1122026-09-04
00840113233502BovieH1212026-09-04
00840113233526BovieHISL2026-09-04
00840113237326BovieESP1N2026-09-04
00840113237340BovieESP1H2026-09-04
00840113237593BovieESP7N2026-09-04
00840113237623BovieESP7H2026-09-04
00840113237661BovieESP6N2026-09-04
00840113237692BovieESP6H2026-09-04
00840113242573BovieST052026-09-04

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