FDA.reportPublic FDA data

NA

Primary DI
10705034466316
Brand
NA
Company
DEPUY SPINE, LLC
Model
698340630
Catalog number
698340630
Device description
MODIFIED INSTRUMENT RETRACTOR BLADE 40mm
Published
2017-02-28
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
GADRETRACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034466316PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503446631610705034466316

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retractor/retraction system blade, reusableA distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge to separate the margins of a wound/incision during a surgical procedure. It is intended to be attached to the frame (e.g., mounting ring/bar) of a surgical retraction system, or may be fixed onto a retractor handle; it does not include a handle. It is a metal device, sometimes referred to as a variable or vario retractor blade when assembled with a separate retractor handle, because it is available in a variety of lengths and sizes. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
107105876
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034471716N/A6983411716983411712022-10-07
10705034570105N\A6983447336983447332022-10-07
10705034570211N/A6983447246983447242022-10-07
10705034570228N\A6983447346983447342022-10-07
10705034570433N/A6983447266983447262022-10-07
10705034570501N\A6983447326983447322022-10-07
10705034570624N/A6983447286983447282022-10-07
10705034570693N\A6983447316983447312022-10-07
10705034570723N/A6983447276983447272022-10-07
10705034458267N/A6983393806983393802022-02-02
10705034137049BENGAL1873011131873011132015-09-24
10705034137056BENGAL1873011141873011142015-09-24
10705034137063BENGAL1873011151873011152015-09-24
10705034137070BENGAL1873011161873011162015-09-24
10705034585321TRIALTIS Spine System5560-12-4560FS5560124560FS2026-05-18
10705034585796TRIALTIS Spine System5560-12-4560S5560124560S2026-05-18
10705034604466TRIALTIS Spine System5560-12-7025CS5560127025CS2026-05-18
10705034359007SPOTLIGHT2829509002829509002016-06-30
10705034217727PIPELINE2871050612871050612019-06-06
10705034217789PIPELINE2871050852871050852019-06-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091100ELMED INCORPORATEDELMED INCORPORATEDGAD2026-05-26
00198506091117ELMED INCORPORATEDELMED INCORPORATEDGAD2026-05-26
00810220800164Adler Instrument CompanyAdler, Inc.GAD2026-05-26
00199150071685Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071692Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071708Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071715Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071722Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071739Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071746Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071753Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071760Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071777Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071784Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071791Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071807Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071814Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150076444Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-23
00810143905779SURGIPROSSurgipros, LLCGAD2026-05-23
00810212930480SURGIPROSSurgipros, LLCGAD2026-05-22
00810212930510SURGIPROSSurgipros, LLCGAD2026-05-22
00810212930534SURGIPROSSurgipros, LLCGAD2026-05-22
M209232580Hintermann CompressorBIOPRO, INC.GAD2026-05-22
M209232590Hintermann DistractorBIOPRO, INC.GAD2026-05-22
00198506089763ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-24
00198506089770ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-24
00198506089787ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-24
00841536148008ThompsonThompson Surgical Instruments, Inc.GAD2026-03-24
00190776418342MillenniumAvalign Technologies, Inc.GAD2026-03-23
00190776418359MillenniumAvalign Technologies, Inc.GAD2026-03-23