FDA.reportPublic FDA data

Symmetry Surgical®

Primary DI
00887482173817
Brand
Symmetry Surgical®
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
61-0396
Catalog number
61-0396
Device description
Knife, House Incudostapedial Joint, Angled 20°, 0.5 mm x 1.5 mm Blade, 6 1/2 in
Published
2024-08-12
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
HTSKnife, Orthopedic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTSKnife, OrthopedicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887482173817PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482173817008874821738178874821738170887482173817

GMDN Terms#

Term, Definition table
TermDefinition
Sternum knifeA heavy-duty, hand-held manual surgical instrument designed for cutting into the sternum (the breastbone). It typically has a T-shaped handle to allow the application of pressure to the blade which descends from the handle in a thick shaft terminating in various contours. It is typically made of high-grade stainless steel; its handle may be made of a synthetic polymer (e.g., Tufnol). 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
00841785112812Symmetry Olsen08-0089I08-0089I2018-05-22
00841785113321Symmetry Olsen08-009008-00902018-08-22
00887482139806Symmetry Malis®08-0089I08-0089I2016-05-24
00887482139820Symmetry Malis®08-009008-00902016-05-24
00841785112539Symmetry Olsen08-004508-00452017-11-02
00841785112805Symmetry Olsen08-008908-00892018-05-22
00841785113338Symmetry Olsen08-0047I08-0047I2018-08-22
00887482139547Symmetry Semkin08-004508-00452016-05-04
00887482139561Symmetry Hardy™08-0047I08-0047I2016-05-26
00887482139578Symmetry Surgical08-004808-00482016-05-26
00887482139653Symmetry Surgical08-005908-00592016-05-26
00887482139790Symmetry Malis®08-008908-00892016-05-17
00841785112317Symmetry Olsen08-0000I08-0000I2017-11-02
00841785112331Symmetry Olsen08-000108-00012017-11-02
00841785112348Symmetry Olsen08-0001I08-0001I2017-11-02
00841785112355Symmetry Olsen08-000408-00042017-11-02
00841785112362Symmetry Olsen08-0004I08-0004I2017-11-02
00841785112379Symmetry Olsen08-000508-00052017-11-02
00841785112393Symmetry Olsen08-000708-00072017-11-02
00841785112423Symmetry Olsen08-000908-00092017-11-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974940307236endophixSuzhou Endophix Co., Ltd.HTS2026-06-23
20653405990366Infinity™Conmed CorporationHTS2026-06-10
20653405990373Infinity™Conmed CorporationHTS2026-06-10
20653405990380Infinity™Conmed CorporationHTS2026-06-10
20653405990397Infinity™Conmed CorporationHTS2026-06-10
20653405990403Infinity™Conmed CorporationHTS2026-06-10
20653405990410Infinity™Conmed CorporationHTS2026-06-10
00192896122796McIlwraith Bistouri KnifeSONTEC INSTRUMENTS, INC.HTS2026-03-10
00853508002645BE-ST Sheathed Bayonet Surgical Knife Lacey Manufacturing Company, LLCHTS2026-03-02
00853508002539BE-ST Sheathed Bayonet Surgical Knife Lacey Manufacturing Company, LLCHTS2026-02-16
00840967154527SigmaALPHATEC SPINE, INC.HTS2025-07-23
00192896121560Arthroscopic Bayonet KnifeSONTEC INSTRUMENTS, INC.HTS2025-05-14
10888277392687MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-04-17
00853508002621BESTLacey Manufacturing Company, LLCHTS2025-03-25
10080196392582MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-22
10080196392636MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10080196392643MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10080196392667MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392564MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392571MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392588MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392595MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392601MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392618MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392625MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392632MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392649MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392656MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392663MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392670MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21