FDA.reportPublic FDA data

Bard-Parker® SafeSwitch™ Disposable Scalpel Handle Cover

Primary DI
00840113204632
Brand
Bard-Parker® SafeSwitch™ Disposable Scalpel Handle Cover
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
ST-830D
Device description
Intended to be used as an indicator only and not for accurate measurements
Published
2021-02-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSMTRAY, SURGICAL, INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840113204618PackageGS14In Commercial Distribution
00840113204656PackageGS18In Commercial Distribution
00840113204632PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840113204618008401132046188401132046180840113204618
00840113204656008401132046568401132046560840113204656
00840113204632008401132046328401132046320840113204632

GMDN Terms#

Term, Definition table
TermDefinition
Scalpel handle, single-useA sterile device that is an interchangeable component of a scalpel and that functions as a handle designed to mount a compatible blade. This device with the blade become a single-bladed surgical instrument intended to be used by a physician for cutting or dissecting tissue. The device is typically made of metal (e.g., stainless steel or brass). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(616)698-7100customerservice@aspensurgical.com

Regulatory Flags#

DUNS number
027680821
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
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
00840286860086Consensus Knee SystemShalby Advanced Technologies, Inc.FSM2026-07-09
M697X07900081Silex Sacroiliac Joint Fusion SystemXtant Medical Holdings, Inc.FSM2026-07-08
00840456220283JMUJMU DENTAL, INCFSM2026-07-07
00190446907466EF1Medshape, Inc.FSM2026-06-25
00190446907473EF1Medshape, Inc.FSM2026-06-25
00190776421724MillenniumAvalign Technologies, Inc.FSM2026-06-24
00885556924730EVOSSmith & Nephew, Inc.FSM2026-06-24
00840456200308JMUJMU DENTAL, INCFSM2026-06-23
00840456200315JMUJMU DENTAL, INCFSM2026-06-23
00840456201176JMUJMU DENTAL, INCFSM2026-06-23
00840456201206JMUJMU DENTAL, INCFSM2026-06-23
00840456201213JMUJMU DENTAL, INCFSM2026-06-23
00840456201220JMUJMU DENTAL, INCFSM2026-06-23
00840456201237JMUJMU DENTAL, INCFSM2026-06-23
00840456201244JMUJMU DENTAL, INCFSM2026-06-23
00840456201251JMUJMU DENTAL, INCFSM2026-06-23
00840456201268JMUJMU DENTAL, INCFSM2026-06-23
00840456206706JMUJMU DENTAL, INCFSM2026-06-23
00840456206713JMUJMU DENTAL, INCFSM2026-06-23
00840456207000JMUJMU DENTAL, INCFSM2026-06-23
00840456214077JMUJMU DENTAL, INCFSM2026-06-23
00840456214084JMUJMU DENTAL, INCFSM2026-06-23
00840456214091JMUJMU DENTAL, INCFSM2026-06-23
00840456214107JMUJMU DENTAL, INCFSM2026-06-23
00840456214114JMUJMU DENTAL, INCFSM2026-06-23
00840456214121JMUJMU DENTAL, INCFSM2026-06-23
00840456215098JMUJMU DENTAL, INCFSM2026-06-23
00840456215111JMUJMU DENTAL, INCFSM2026-06-23
00840456215128JMUJMU DENTAL, INCFSM2026-06-23
00840456217580JMUJMU DENTAL, INCFSM2026-06-23