FDA.reportPublic FDA data

Symmetry Shea

Primary DI
00887482116548
Brand
Symmetry Shea
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
62-0475
Device description
Symmetry® Searcher, Shea Forward, 45
Published
2024-09-09
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
JZCSearcher, Mastoid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JZCSearcher, MastoidEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887482116548PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482116548008874821165488874821165480887482116548

GMDN Terms#

Term, Definition table
TermDefinition
Middle ear file/raspA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth at the distal working end designed to scrape and smooth the bony structures of the middle ear. It is typically used during ear/nose/throat (ENT) or plastic surgery; it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle45degree

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
00840113233281BovieH1002026-09-04
00840113233304BovieH1012026-09-04
00840113233328BovieH101-ADH2026-09-04
00840113233342BovieH1032026-09-04
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840183504083BR Surgical, LLCBR Surgical, LLCJZC2024-03-21
00840183505356BR Surgical, LLCBR Surgical, LLCJZC2024-03-21
00840183520779BR Surgical, LLCBR Surgical, LLCJZC2024-03-21