FDA.reportPublic FDA data

Symmetry Surgical®

Primary DI
00887482114223
Brand
Symmetry Surgical®
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
61-0438
Catalog number
61-0438
Device description
Symmetry® Fenestrometer, Paparella, 1 mm & 0.5 mm Markings, 4 mm Head, 6 1/2 in
Published
2024-08-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JYJGauge, Measuring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYJGauge, MeasuringEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887482114223PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482114223008874821142238874821142230887482114223

GMDN Terms#

Term, Definition table
TermDefinition
Mastoid gaugeA manual surgical instrument designed for introduction into and calibration of the mastoid bone antrum during surgical procedures (e.g., mastoidectomy). It is typically a slender, hand-held, calibrated (e.g., in millimetres) metallic device with an angled blunt distal end (also known as a searcher or seeker). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
04054462906819evonosevonos GmbH & Co. KGJYJ2026-08-21
04054462908080evonosevonos GmbH & Co. KGJYJ2026-08-21
04054462907588evonosevonos GmbH & Co. KGJYJ2026-08-18
04054462907595evonosevonos GmbH & Co. KGJYJ2026-08-18
04054462907601evonosevonos GmbH & Co. KGJYJ2026-08-18
04054462908097evonosevonos GmbH & Co. KGJYJ2026-08-18
09348811109439INKAThe Trustee for KAISER FAMILY TRUSTJYJ2026-05-29
14250368861062KURZ Meter incl. TrayHeinz Kurz GmbHJYJ2026-05-21
14250368862557Sizer OMEGA CONNECTORHeinz Kurz GmbHJYJ2026-05-21
14250368865404AC Sizer System PartialHeinz Kurz GmbHJYJ2026-05-21
14250368865503AC Sizer System TotalHeinz Kurz GmbHJYJ2026-05-21
09348811109408INKAThe Trustee for KAISER FAMILY TRUSTJYJ2026-04-24
09348811109415INKAThe Trustee for KAISER FAMILY TRUSTJYJ2026-04-24
09348811109446INKAThe Trustee for KAISER FAMILY TRUSTJYJ2026-03-18
09348811109422INKAThe Trustee for KAISER FAMILY TRUSTJYJ2025-12-01
00844505014700SKULL BASEGrace Medical, Inc.JYJ2025-09-26
00844505014663OFFSET TITANIUM WILDCAT ALTOGrace Medical, Inc.JYJ2025-07-17
00844505014649NYTEBYTEGrace Medical, Inc.JYJ2025-07-02
00757770501274Bausch + LombBausch & Lomb IncorporatedJYJ2025-06-03
00194613116965MSI Precision Specialty InstrumentsMed Saver, Inc.JYJ2025-03-21
00848253004006Blom-Singer® Nasal Septal Perforation Sizing ToolFreudenberg Medical, LLCJYJ2025-03-14
00840183527501BR Surgical, LLCBR Surgical, LLCJYJ2024-11-26
00887482113387Symmetry AustinASPEN SURGICAL PRODUCTS, INC.JYJ2024-08-12
00190776378448MillenniumAvalign Technologies, Inc.JYJ2023-11-13
00844505014328BENSON UNIVERSAL IMPLANT SIZERGrace Medical, Inc.JYJ2023-09-27
00190776289232MillenniumAvalign Technologies, Inc.JYJ2023-06-23
00842331168475Novo Surgical Inc. NOVO SURGICAL, INC.JYJ2022-11-13
00842331131288Novo Surgical Inc. NOVO SURGICAL, INC.JYJ2022-11-10
04250381854891Castroviejo nasal caliperSpiggle & Theis Medizintechnik GmbHJYJ2022-09-16
04250676733726Joseph placing instrumentSpiggle & Theis Medizintechnik GmbHJYJ2022-09-16