FDA.reportPublic FDA data

Symmetry Ballenger

Primary DI
00887482012772
Brand
Symmetry Ballenger
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
40-6772
Catalog number
40-6772
Device description
Symmetry® Knife, Ballenger Swivel, 5 mm Blade Width, Straight
Published
2022-09-16
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
EMFKnife, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMFKnife, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887482012772PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482012772008874820127728874820127720887482012772

GMDN Terms#

Term, Definition table
TermDefinition
Cartilage knifeA hand-held manual surgical instrument designed for cutting, shaving or shaping cartilage during a surgical intervention. It is typically a one-piece instrument with a sharp, single-edged, cutting blade at the distal end which is normally very long, similar in shape to a scalpel blade, and may vary in length and size; it has a handle at the proximal end. It is normally made of high-grade stainless steel. Also known as a chondrotome, a cartilage knife can also be used in pathology procedures. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width5Millimeter

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
00841785102714Symmetry Olsen20-1040I20-1040I2016-09-09
00841785102769Symmetry Olsen20-106020-10602016-09-06
00841785102776Symmetry Olsen20-1060I20-1060I2016-09-06
00841785102899Symmetry Olsen20-108020-10802016-09-06
00841785102905Symmetry Olsen20-1080I20-1080I2016-09-06
00841785102950Symmetry Olsen20-108220-10822016-09-06
00841785102967Symmetry Olsen20-1082I20-1082I2016-09-06
00841785102974Symmetry Olsen20-1082IMT20-1082IMT2016-09-07
00841785103025Symmetry Olsen20-109020-10902016-09-06
00841785103032Symmetry Olsen20-1090I20-1090I2016-09-06
00841785103049Symmetry Olsen20-1090IMT20-1090IMT2016-09-07
00841785103162Symmetry Olsen20-1162I20-1162I2016-09-06
00841785103285Symmetry Olsen20-1190I20-1190I2016-09-06
00841785103667Symmetry Olsen20-1325I20-1325I2016-09-08
00841785103674Symmetry Olsen20-1325IMT20-1325IMT2016-09-08
00841785103735Symmetry Olsen20-1330I20-1330I2016-09-08
00841785103742Symmetry Olsen20-1330IMT20-1330IMT2016-09-09
00841785103803Symmetry Olsen20-1340I20-1340I2016-09-06
00841785103865Symmetry Olsen20-1350I20-1350I2016-09-06
00841785103988Symmetry Olsen20-1360I20-1360I2016-09-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810189450691Surgical DesignSurgical Design, Inc.EMF2026-06-06
00810189450707Surgical DesignSurgical Design, Inc.EMF2026-06-06
00198506085659ELMED INCORPORATEDELMED INCORPORATEDEMF2025-10-02
10888277370647MEDLINEMEDLINE INDUSTRIES, INC.EMF2025-02-14
10888277377615MEDLINEMEDLINE INDUSTRIES, INC.EMF2025-01-21
00860010523902VECTRRafael Medical Devices, LLCEMF2025-01-10
00842180160613ELMEDELMED INCORPORATEDEMF2023-01-30
00842180147737ELMEDELMED INCORPORATEDEMF2022-12-22
14026704810861PILLINGTELEFLEX INCORPORATEDEMF2022-12-08
00192896113701Cottle Mucosa KnifeSONTEC INSTRUMENTS, INC.EMF2022-09-15
00847399017239MicroAire® Microaire Surgical Instruments LLCEMF2022-06-15
00847399017246MicroAire® Microaire Surgical Instruments LLCEMF2022-06-15
10888277370623MedlineMEDLINE INDUSTRIES, INC.EMF2022-05-12
10888277370630MedlineMEDLINE INDUSTRIES, INC.EMF2022-05-12
00847399016003MicroAire® Microaire Surgical Instruments LLCEMF2021-10-25
00847399016010MicroAire® Microaire Surgical Instruments LLCEMF2021-10-25
00847399016034MicroAire® Microaire Surgical Instruments LLCEMF2021-10-25
00847399016935MicroAire® Microaire Surgical Instruments LLCEMF2021-10-25
00847399016942MicroAire® Microaire Surgical Instruments LLCEMF2021-10-25
20630140057523CARDINAL HEALTHCardinal Health 200, LLCEMF2021-06-11
20630140057530CARDINAL HEALTHCardinal Health 200, LLCEMF2021-06-11
00848782025527StylusSurgical Specialties México, S. de R.L. de C.V.EMF2021-03-29
00848782025541StylusSurgical Specialties México, S. de R.L. de C.V.EMF2021-03-29
00848782025572StylusSurgical Specialties México, S. de R.L. de C.V.EMF2021-03-29
00848782025602StylusSurgical Specialties México, S. de R.L. de C.V.EMF2021-03-29
00848782025633StylusSurgical Specialties México, S. de R.L. de C.V.EMF2021-03-29
00848782025657StylusSurgical Specialties México, S. de R.L. de C.V.EMF2021-03-29
00848782025671StylusSurgical Specialties México, S. de R.L. de C.V.EMF2021-03-29
00848782025688StylusSurgical Specialties México, S. de R.L. de C.V.EMF2021-03-29
00848782025763StylusSurgical Specialties México, S. de R.L. de C.V.EMF2021-03-29