FDA.reportPublic FDA data

Larson Bladed Lancet

Primary DI
08503590070801
Brand
Larson Bladed Lancet
Company
CLEARPOINT NEURO, INC.
Model
NGS-BL-01
Catalog number
NGS-BL-01
Device description
Bladed Lancet
Published
2020-06-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HAOInstrument, Surgical, Non-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAOInstrument, Surgical, Non-PoweredNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08503590070801PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08503590070801085035900708018503590070801

GMDN Terms#

Term, Definition table
TermDefinition
Scalpel, single-useA hand-held, manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade is typically made of high-grade stainless steel alloy or carbon steel and the handle is often made of plastic. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
949-900-6833info@clearpointneuro.com

Regulatory Flags#

DUNS number
959181160
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
00850013266012Hummingbird® Patient MonitorHICP200HICP2002019-10-14
00850013266029Hummingbird® SynergyDuoH610H6102019-10-10
00850013266036Hummingbird® Parenchymal CatheterH110H1102019-10-10
00850013266180Hummingbird® Cranial Access Kit IC42-DIC42-D2020-01-29
00850013266197Hummingbird® Cranial Access KitIC42IC422020-01-29
00850013266203IRRAflow Tube SetICDS 030ICDS 0302023-11-02
00850013266234HummingbirdCK 402023-10-13
00850013266241HummingbirdCK 422023-10-13
00850013266272IRRAflow Cranial Access BoltICB 0102025-07-24
00868643000401IRRAflow®ICCU 020ICCU 0202019-01-22
00868643000463IRRAflow Laser Leveler PackageICLS 010ICLS 0102024-06-10
00868643000470IRRAflow Drainage Collection SystemDCS 010DCS 0102019-09-30
00868643000487Hummingbird® Cranial Access KitIC40DIC40-D2019-10-10
00868643000494Hummingbird® Cranial Access KitIC40IC402019-10-10
00850013266258IRRAflow Catheter 2.0+ICAT 0302025-05-07
00850013266005Hummingbird Cranial Access KitIC40IC402023-12-08
00850013266227Hummingbird Cranial Access KitIC422023-12-08
00850013266104Hummingbird® HICP200 Monitor Interconnect Cable - Spacelabs 6 Pin Monitor700033270003322020-05-28
00868643000418IRRAflow® Cassette and Tube SetICDS 020ICDS 0202019-01-22
00868643000425IRRAflow® 1.5 CatheterICGS 010ICGS 0102019-01-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G586N93065370Novo SurgicalNOVO SURGICAL, INC.HAO2024-02-22
G586N93065380Novo SurgicalNOVO SURGICAL, INC.HAO2024-02-22
G28435301ScrewdriverNeurovention LLCHAO2022-06-21
07613327262322XIAStryker CorporationHAO2019-11-21
07613327264432XIA 4.5Stryker CorporationHAO2019-11-21
07613327264951XIA 3Stryker CorporationHAO2019-11-21
07613327271447OASYSStryker CorporationHAO2019-11-21
07613327276176RADIUSStryker CorporationHAO2019-11-21
07613327263787RELIANCE LITeStryker CorporationHAO2019-11-20
07613327263923RELIANCE LITeStryker CorporationHAO2019-11-20
07613327265897RELIANCE LITeStryker CorporationHAO2019-11-20
07613327265910RELIANCE LITeStryker CorporationHAO2019-11-20
07613327265934RELIANCE LITeStryker CorporationHAO2019-11-20
07613327266016RELIANCE LITeStryker CorporationHAO2019-11-20
10381780167778Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAO2018-10-23
10381780222682Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAO2018-09-12
10381780223276Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAO2018-09-12
10381780223283Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAO2018-09-12
10381780223368Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAO2018-09-12
10381780223429Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAO2018-09-12
10381780180647Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAO2018-04-09
10381780180654Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAO2018-04-09
10381780180661Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAO2018-04-09
10381780180678Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAO2018-04-09
10381780180722Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAO2018-04-09
10381780180920Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAO2018-04-09
10381780180937Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAO2018-04-09
10381780188742Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAO2018-04-09
10381780188759Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAO2018-04-09
10381780223351Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAO2018-04-09