FDA.reportPublic FDA data

ReLine

Primary DI
00887517474803
Brand
ReLine
Company
Nuvasive, Inc.
Model
10000107
Device description
GSB Handle, Dual Ended Egg
Published
2018-09-24
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
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887517474803PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887517474803008875174748038875174748030887517474803

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(858)909-1800RA_UDI@nuvasive.com
+1800-475-9131nuvainfo@globusmedical.com

Regulatory Flags#

DUNS number
053950783
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
00887517656582ReLine13125560131255602026-04-15
00887517377692CoRoent68510122015-10-24
00887517390516CoRoent69102452015-10-24
00195377006424CoRoent6791713P26791713P22026-05-08
00195377006431CoRoent6791712P26791712P22026-05-08
00887517051905CoRoent6791715P26791715P22026-05-08
00887517051912CoRoent6791716P26791716P22026-05-08
00887517051929CoRoent6791812P26791812P22026-05-08
00887517051936CoRoent6791813P26791813P22026-05-08
00887517051943CoRoent6791814P26791814P22026-05-08
00887517051950CoRoent6791815P26791815P22026-05-08
00887517051967CoRoent6791816P26791816P22026-05-08
00887517180513MaXcess32000282022-07-20
00887517063434MaXcess10109872019-11-21
00887517074973MaXcess10254612019-11-21
00887517183323MaXcess32001202019-11-21
00887517183378MaXcess32002202019-11-21
00887517206084MaXcess34000332019-11-21
00887517206572MaXcess34000442019-11-21
00887517497222MaXcess32410022019-11-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M697X07900671Silex Sacroiliac Joint Fusion SystemXtant Medical Holdings, Inc.LXH2026-07-08
M7403030001Discectomy SetSPINEOLOGY INC.LXH2026-07-08
M7403030002Discectomy SetSPINEOLOGY INC.LXH2026-07-08
M7403030069Discectomy SetSPINEOLOGY INC.LXH2026-07-08
M7403030070Discectomy SetSPINEOLOGY INC.LXH2026-07-08
M7403030071Discectomy SetSPINEOLOGY INC.LXH2026-07-08
00196449017645Anatomic Access LLIFTyber Medical, LLCLXH2026-06-23
00196449035373Anatomic Access LLIFTyber Medical, LLCLXH2026-06-23
008500783961982.2 TITAN Nail Instrument KitEca Medical InstrumentsLXH2026-06-23
008500783962043.0 TITAN Nail Instrument KitEca Medical InstrumentsLXH2026-06-23
008500783962284.0 TITAN Nail Instrument KitEca Medical InstrumentsLXH2026-06-23
008500783962352.2-4.0 TITAN Nail SizerEca Medical InstrumentsLXH2026-06-23
008500783962422.2 TITAN Nail Accessory KitEca Medical InstrumentsLXH2026-06-23
008500783962593.0 TITAN Nail Accessory KitEca Medical InstrumentsLXH2026-06-23
008500783962734.0 TITAN Nail Accessory KitEca Medical InstrumentsLXH2026-06-23
00193982621476ORTHOPEDIC MANUAL SURGICAL INSTRUMENTGLOBUS MEDICAL, INC.LXH2026-06-10
00193982683214ORTHOPEDIC MANUAL SURGICAL INSTRUMENTGLOBUS MEDICAL, INC.LXH2026-06-10
008401944957693P Small-Mini Frag SystemORTHOPEDIATRICS CORP.LXH2026-06-10
008401944957763P Small-Mini Frag SystemORTHOPEDIATRICS CORP.LXH2026-06-10
008401944957833P Small-Mini Frag SystemORTHOPEDIATRICS CORP.LXH2026-06-10
008401944957903P Small-Mini Frag SystemORTHOPEDIATRICS CORP.LXH2026-06-10
008401944958063P Small-Mini Frag SystemORTHOPEDIATRICS CORP.LXH2026-06-10
00857915007774Measuring DeviceA.M. SURGICAL, INC.LXH2026-06-10
00889795154552Spider Monkey Bone Transport SystemParagon 28, Inc.LXH2026-06-10
00889795154569Spider Monkey Bone Transport SystemParagon 28, Inc.LXH2026-06-10
00889795154576Spider Monkey Bone Transport SystemParagon 28, Inc.LXH2026-06-10
00841732164284GENERIC Surgical InstrumentsCTL Medical CorporationLXH2023-09-15
00841732164123GENERIC Surgical InstrumentsCTL Medical CorporationLXH2023-09-14
00841732164147GENERIC Surgical InstrumentsCTL Medical CorporationLXH2023-09-14
00841732164154GENERIC Surgical InstrumentsCTL Medical CorporationLXH2023-09-14