FDA.reportPublic FDA data

N/A

Primary DI
00889095207637
Brand
N/A
Company
GLOBUS MEDICAL, INC.
Model
675.608
Device description
Scraper, 8mm
Published
2016-04-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00889095207637PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889095207637008890952076378890952076370889095207637

GMDN Terms#

Term, Definition table
TermDefinition
Implant handling forceps, scissors-likeA hand-held manual surgical instrument with blades designed to grasp and manipulate surgical implants/devices (excluding sutures) during implantation; it is not intended for use on soft tissues, not an ophthalmic device, and is not a dedicated tissue clip applier. It has a scissors-like, self-retaining design with ring handles, is made of high-grade stainless steel and is available in various sizes. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height8Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(610)930-1800info@globusmedical.com

Regulatory Flags#

DUNS number
139105691
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
00889095205831XEMPLIFI8103.0001S2015-10-10
00889095205848XEMPLIFI8103.0005S2015-10-10
00889095205855XEMPLIFI8103.0010S2015-10-10
00889095205862XEMPLIFI8103.0101S2015-10-10
00889095205879XEMPLIFI8103.0105S2015-10-10
00889095205886XEMPLIFI8103.0110S2015-10-10
00889095205893XEMPLIFI8103.0201S2015-10-10
00889095205909XEMPLIFI8103.0203S2015-10-10
00889095205916XEMPLIFI8103.0208S2015-10-10
00889095205923XEMPLIFI8103.0210S2015-10-10
00889095401820ANTHEM2171.65092171.65092026-09-25
00889095401844ANTHEM2171.65112171.65112026-09-25
00889095401868ANTHEM2171.65132171.65132026-09-25
00889095401882ANTHEM2171.65152171.65152026-09-25
00889095401905ANTHEM2171.65172171.65172026-09-25
00889095401929ANTHEM2171.65192171.65192026-09-25
00889095402285ANTHEM2171.65552171.65552026-09-25
00889095402438ANTHEM2171.65702171.65702026-09-25
00889095402483ANTHEM2171.65752171.65752026-09-25
00889095402537ANTHEM2171.65802171.65802026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000880118MSB Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-10-23
00842528130056OSTEOMEDOSTEOMED LLCLXH2026-10-23
00888867550391Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550407Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550414Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550421Arthrex®ARTHREX, INC.LXH2026-10-23
04251631412144BEE PLIFNGMedical GmbHLXH2026-10-23
M739153997700Cross Connector DriverCAPTIVA SPINE, INC.LXH2026-10-23
M739153998800Cross Connector Counter TorqueCAPTIVA SPINE, INC.LXH2026-10-23
M739243501000Blade DilatorCAPTIVA SPINE, INC.LXH2026-10-23
M739243502000Parallel GuideCAPTIVA SPINE, INC.LXH2026-10-23
M739243503000In-Line HandleCAPTIVA SPINE, INC.LXH2026-10-23
M739243504000Tissue DilatorCAPTIVA SPINE, INC.LXH2026-10-23
M739243505000Tissue ProtectorCAPTIVA SPINE, INC.LXH2026-10-23
M739243506000Adjustable Parallel GuideCAPTIVA SPINE, INC.LXH2026-10-23
M739243507000Impaction SleeveCAPTIVA SPINE, INC.LXH2026-10-23
M739243508000Self-Feeding DrillCAPTIVA SPINE, INC.LXH2026-10-23
M739243509000Implant Filling TubeCAPTIVA SPINE, INC.LXH2026-10-23
M739243511000Plunger RodCAPTIVA SPINE, INC.LXH2026-10-23
M739243512000Cannulated Drill, 7mmCAPTIVA SPINE, INC.LXH2026-10-23
M7399830151066mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M7399830151077mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M7399830151088mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M7399830151099mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M73998301511010mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M73998301511111mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M73998301511212mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M739983101200Coupling - Square ConnectCAPTIVA SPINE, INC.LXH2026-10-23
M739983240300Impaction T-HandleCAPTIVA SPINE, INC.LXH2026-10-23
M739985202530Marking PinCAPTIVA SPINE, INC.LXH2026-10-23