FDA.reportPublic FDA data

SOLUSTAPLE®

Primary DI
10381780045953
Brand
SOLUSTAPLE®
Company
NEWDEAL
Model
119403ND
Device description
The staple holder and impactor is used to handle and insert the SOLUS 26° staples.
Published
2017-05-26
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
HWAIMPACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWAImpactorOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780045953PrimaryGS10
M248119403ND1SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178004595310381780045953

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone staple driverA hand-held surgical instrument designed to impart force on a bone staple, or on another instrument, to insert the bone staple typically into fractured bone. The distal end is typically shaped to mate with the bone staple. The proximal end is designed to absorb and transmit an impact force. It is typically made of high-grade stainless steel or titanium (Ti). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
536935331
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780041771QWIX®119932ND2017-05-26
10381780042099Hallu®-FIX129930ND2017-05-26
10381780042136Hallu®-FIX129935ND2017-05-26
10381780042266ADVANSYS®169101ND2017-05-26
10381780042273ADVANSYS®169102ND2017-05-26
10381780042280ADVANSYS®169104ND2017-05-26
10381780042327ADVANSYS®188201ND2017-05-26
10381780042334ADVANSYS®188202ND2017-05-26
10381780042419IPP-ON®239000ND2017-05-26
10381780042426IPP-ON®239001ND2017-05-26
10381780042778PANTA®519920ND2017-05-26
10381780042822SURFIX®SET000ND2017-05-26
10381780042839SURFIX®SET100ND2017-05-26
10381780042846SURFIX®SET101ND2017-05-26
10381780052005SURFIX®219765ND2017-05-26
10381780052036SURFIX®MA003ND2017-05-26
10381780052166METIS®119601ND2017-05-26
10381780052999PANTA®519130ND2017-05-31
10381780126539TIBIAXYS®159985ND2017-05-26
10381780044574PANTA XL510004ND510004ND2017-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556925690NASmith & Nephew, Inc.HWA2026-06-04
10603295543718ATTUNEDEPUY (IRELAND)HWA2025-10-31
10603295543725ATTUNEDEPUY (IRELAND)HWA2025-10-31
00841732162709GENERIC Surgical InstrumentsCTL Medical CorporationHWA2023-09-27
00841732162716GENERIC Surgical InstrumentsCTL Medical CorporationHWA2023-09-27
07613327538601INSTRUMENTHowmedica Osteonics Corp.HWA2023-06-30
10603295549581INHANCEDEPUY (IRELAND)HWA2023-02-28
10603295539346INHANCEDEPUY (IRELAND)HWA2021-08-30
07640178983052JULIET ® INSTRUMENTATIONSpineArt SAHWA2019-02-01
10705034717364NASynthes GmbHHWA2019-01-18
10603295423324ATTUNEDEPUY (IRELAND)HWA2018-09-24
M684201620111MICROPORTMicroport Orthopedics Inc.HWA2018-09-13
10705034720883NASYNTHES (U.S.A.) LPHWA2018-08-17
10381780408451Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWA2018-08-16
10381780479406Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWA2018-08-16
10381780266389Integra™Allograft Wedge SystemAscension Orthopedics, Inc.HWA2018-04-13
10381780282457Integra® PyroCarbonAscension Orthopedics, Inc.HWA2018-04-13
10381780279495K2™ Hemi Toe Implant SystemAscension Orthopedics, Inc.HWA2018-04-10
10381780279907KGTI™ Kinetik Great Toe Implant SystemAscension Orthopedics, Inc.HWA2018-04-10
10381780224815Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWA2018-03-23
10381780224822Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWA2018-03-23
10381780224839Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWA2018-03-23
10381780224846Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWA2018-03-23
10381780224853Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWA2018-03-23
10381780224860Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWA2018-03-23
10381780224877Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWA2018-03-23
10381780224884Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWA2018-03-23
10381780224891Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWA2018-03-23
10381780278283Integra® Freedom Wrist Arthroplasty SystemAscension Orthopedics, Inc.HWA2018-03-09
10381780278290Integra® Freedom Wrist Arthroplasty SystemAscension Orthopedics, Inc.HWA2018-03-09