FDA.reportPublic FDA data

JosNoe Medical Inc

Primary DI
00850003294094
Brand
JosNoe Medical Inc
Company
JOSNOE MEDICAL, INC.
Model
JNM-LG01
Device description
LumaGuard: Light Shield for Fiber Optic Light Cables
Published
2019-11-04
Public version status
New
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
NWVLaparoscopic Accessories, Gynecologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWVLaparoscopic Accessories, GynecologicObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850003294094PackageGS115In Commercial Distribution
00850003294087PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850003294094008500032940948500032940940850003294094
00850003294087008500032940878500032940870850003294087

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic surgical procedure kit, non-medicated, single-useA collection of various sterile laparoscopic and surgical instruments (e.g., access cannulae, forceps), dressings, and additional materials intended to be used specifically to perform a laparoscopic surgical procedure. It does not contain pharmaceuticals. It may be referred to as a procedure tray. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
965627859
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850003294834GynexGYN SE82002024-11-08
00850003294285JosNoe Medical IncJNM-2000162019-11-05
00850003294384JosNoe Medical IncJNM-02032019-11-05
00850003294421JosNoe Medical IncJNM-OC84S2019-11-05
00850003294452JosNoe Medical IncJNM-OC84S-RTP2019-11-05
00850003294483JosNoe Medical IncHS-1002019-11-05
00850003294506JosNoe Medical IncHS-100-NSM-502019-11-05
00850003294520JosNoe Medical IncHF-7001S2019-11-05
00850003294230JosNoe Medical IncTM-60002019-10-31
00850003294254JosNoe Medical IncJNM-1222-NSM-502019-10-31
00850003294261JosNoe Medical IncTM-6000-NSM-502019-10-31
00850003294308JosNoe Medical IncSP-1022019-10-31
00850003294339JosNoe Medical IncSP-102-NSM-502019-10-31
00850003294353JosNoe Medical IncSP-1042019-10-31
00850003294155JosNoe Medical IncJNM-12222019-10-28
00850003294223JosNoe Medical IncITF10-NSM-502019-10-02
00850003294124JosNoe Medical IncPFITF-102019-09-11
00850003294117JosNoe Medical IncPS-5002019-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848657078269AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2026-03-02
00190776417390MillenniumAvalign Technologies, Inc.NWV2026-02-27
00190776417406MillenniumAvalign Technologies, Inc.NWV2026-02-27
00190776417451MillenniumAvalign Technologies, Inc.NWV2026-02-27
00198506088520ELMED INCORPORATEDELMED INCORPORATEDNWV2026-02-23
00190776416072MillenniumAvalign Technologies, Inc.NWV2026-02-06
00190776415631MillenniumAvalign Technologies, Inc.NWV2026-02-02
00190776415648MillenniumAvalign Technologies, Inc.NWV2026-02-02
00190776415655MillenniumAvalign Technologies, Inc.NWV2026-02-02
00190776415402MillenniumAvalign Technologies, Inc.NWV2026-01-27
00848657078108AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2026-01-15
00848657078115AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2026-01-15
00848657078122AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2026-01-15
00848657077958AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2026-01-13
00848657077965AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2026-01-13
00848657078009AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2026-01-13
00190776411275MillenniumAvalign Technologies, Inc.NWV2025-09-22
00860003326404AbGrabLapovations, LLCNWV2025-07-25
00190776402440MillenniumAvalign Technologies, Inc.NWV2025-06-23
00190776401733MillenniumAvalign Technologies, Inc.NWV2025-06-12
00190776396107MillenniumAvalign Technologies, Inc.NWV2025-05-09
00190776394936MillenniumAvalign Technologies, Inc.NWV2025-05-08
08904332600513MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDNWV2025-03-10
00198506045370ELMED INCORPORATEDELMED INCORPORATEDNWV2024-12-19
00198506073854ELMED INCORPORATEDELMED INCORPORATEDNWV2024-12-19
00190776389956MillenniumAvalign Technologies, Inc.NWV2024-11-18
00190776389109MillenniumAvalign Technologies, Inc.NWV2024-11-14
00198506017650ELMED INCORPORATEDELMED INCORPORATEDNWV2024-10-25
04547410515893FUJIFILMFUJIFILM CORPORATIONNWV2024-10-04
04547410524284FUJIFILMFUJIFILM CORPORATIONNWV2024-10-04