FDA.reportPublic FDA data

LITe

Primary DI
07613327359572
Brand
LITe
Company
Stryker Corporation
Model
DI_48850100
Catalog number
48850100
Device description
Y-Needle 100
Published
2017-10-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PDQNeurosurgical nerve locator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PDQNeurosurgical Nerve LocatorEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171807000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171807000ES2 Neuromonitoring Accessory InstrumentsStryker Corporation2017-07-18PDQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327359572PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327359572076133273595727613327359572

GMDN Terms#

Term, Definition table
TermDefinition
Bone access cannulaA sterile, sharp, hollow tubular metal instrument designed for percutaneous insertion to provide access to any bone of the body for a bone biopsy needle or guidewire, or for a bone marrow aspiration technique, or for inserting therapeutic materials, including bone cements. It is typically inserted using a stylet under imaging [e.g., fluoroscopic, ultrasonic, computed tomography (CT)] control and has a proximal plastic handgrip to apply manual pressure and twist. This is a single-use device.

Regulatory Flags#

DUNS number
149183167
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327524475Optablate97000151009700-015-1002022-09-23
07613327638233Omnicurve10320150001032-015-0002024-09-03
00857037006075LATERALATSYS24LATSYS242020-01-14
00857037006037LATERALATSYS20LATSYS202020-01-08
07613327060058Precision Ideal Eyes05028190100502-819-0102016-09-23
07613327006223ARIA48755700487557002019-11-20
07613327006919ES2 SPINAL SYSTEM48280082482800822019-11-20
07613327006926ES2 SPINAL SYSTEM48280083482800832019-11-20
07613327006940ES2 SPINAL SYSTEM48280086482800862019-11-20
07613327006957ES2 SPINAL SYSTEM48280087482800872019-11-20
07613327007114ES2 SPINAL SYSTEM48280311482803112019-11-25
07613327007558XIA 348237078482370782019-11-25
07613327007565XIA 348237079482370792019-11-25
07613327067088ACCULIF8003578003572016-09-24
07613327067095ACCULIF8003478003472016-09-24
07613327114799XIA 4.5 EVOLUTION48138140481381402019-11-21
07613327114812XIA 4.5 EVOLUTION48138011R48138011R2019-11-20
07613327114843XIA 4.5 EVOLUTION48138011L48138011L2019-11-20
07613327114850XIA 4.5 EVOLUTION48138101481381012019-11-21
07613327114874ES2 SPINAL SYSTEM48280178482801782019-11-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M68980801D160Fresh Whole Blood Donor Transfusion SetSafeguard US Operating, LLCPDQ2026-05-04
00843059126945MedtronicTEDAN SURGICAL INNOVATIONS, L.L.C.PDQ2026-04-28
00843059126990MedtronicTEDAN SURGICAL INNOVATIONS, L.L.C.PDQ2026-04-28
00190376509747SafeOp 3ALPHATEC SPINE, INC.PDQ2026-03-24
03662674000525PediGuard DSG ConnectSPINEGUARDPDQ2025-09-17
00840067103555Cadwell GuardianCADWELL INDUSTRIES, INC.PDQ2024-11-15
00840067103562Cadwell GuardianCADWELL INDUSTRIES, INC.PDQ2024-11-15
00840067103623Cadwell GuardianCADWELL INDUSTRIES, INC.PDQ2024-11-15
00840067103630Cadwell GuardianCADWELL INDUSTRIES, INC.PDQ2024-11-15
00190376517506SafeOp 3ALPHATEC SPINE, INC.PDQ2024-11-12
00190376530024SafeOp 3ALPHATEC SPINE, INC.PDQ2024-11-12
00840067102992Cadwell GuardianCADWELL INDUSTRIES, INC.PDQ2024-08-23
00190376549392SafeOp 3ALPHATEC SPINE, INC.PDQ2024-07-12
00840067103517Cadwell GuardianCADWELL INDUSTRIES, INC.PDQ2024-06-21
00840067103524Cadwell GuardianCADWELL INDUSTRIES, INC.PDQ2024-06-21
00840067102879Cadwell GuardianCADWELL INDUSTRIES, INC.PDQ2024-03-04
00840067102886Cadwell GuardianCADWELL INDUSTRIES, INC.PDQ2024-03-04
00840067102893Cadwell GuardianCADWELL INDUSTRIES, INC.PDQ2024-03-04
00840067102916Cadwell GuardianCADWELL INDUSTRIES, INC.PDQ2024-03-04
00840067103609Cadwell GuardianCADWELL INDUSTRIES, INC.PDQ2024-03-04
10705034604527TELIGENMedos International SàrlPDQ2024-02-10
00195377153951PULSENuvasive, Inc.PDQ2023-07-11
00195377153968PULSENuvasive, Inc.PDQ2023-07-11
00195377153975PULSENuvasive, Inc.PDQ2023-07-11
00195377060761PULSENuvasive, Inc.PDQ2023-07-06
00195377060778PULSENuvasive, Inc.PDQ2023-07-06
00195377099013PULSENuvasive, Inc.PDQ2023-07-06
00195377153807PULSENuvasive, Inc.PDQ2023-05-02
00195377153814PULSENuvasive, Inc.PDQ2023-05-02
00195377097422NVM5Nuvasive, Inc.PDQ2023-04-13