FDA.reportPublic FDA data

LSL HEALTHCARE

Primary DI
10661392010458
Brand
LSL HEALTHCARE
Company
LSL Industries, LLC
Model
7152I
Catalog number
7152I
Device description
Ear Ulcer Syringe
Published
2025-05-16
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
KCPSYRINGE, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCPSyringe, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10661392010458PackageGS150In Commercial Distribution
00661392010451PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1066139201045810661392010458
00661392010451006613920104516613920104510661392010451

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
046703096
Device count
1
DM exempt
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10661392055657LSL HEALTHCARE162816282025-06-06
10661392000152LSL HEALTHCARE712771272025-05-16
10661392000169LSL HEALTHCARE712871282025-05-16
10661392000206LSL HEALTHCARE750175012025-05-16
10661392000602LSL HEALTHCARE752875282025-05-16
10661392000718LSL HEALTHCAREADC3005ADC30052025-05-16
10661392000824LSL HEALTHCAREADL1007ADL10072025-05-16
10661392000831LSL HEALTHCARE7301A7301A2025-05-16
10661392000916LSL HEALTHCARE710471042025-05-16
10661392001739LSL HEALTHCARE710071002025-05-16
10661392001760LSL HEALTHCARE710571052025-05-16
10661392001777LSL HEALTHCARE710671062025-05-16
10661392001784LSL HEALTHCARE710971092025-05-16
10661392001821LSL HEALTHCARE7128-05247128-05242025-05-16
10661392001845LSL HEALTHCARE713171312025-05-16
10661392001869LSL HEALTHCARE715171512025-05-16
10661392001890LSL HEALTHCARE719671962025-05-16
10661392001913LSL HEALTHCARE7199C7199C2025-05-16
10661392001920LSL HEALTHCARE746174612025-05-16
10661392001999LSL HEALTHCARE750875082025-05-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16971919460494Medi GradeNingbo Albert Novosino Co.,Ltd.KCP2025-11-17
16971919460432Medi GradeNingbo Albert Novosino Co.,Ltd.KCP2025-11-11
00194613021535MSI Precision Specialty InstrumentsMed Saver, Inc.KCP2025-08-01
00194613112639MSI Precision Specialty InstrumentsMed Saver, Inc.KCP2025-08-01
00757770410651Bausch + LombBausch & Lomb IncorporatedKCP2025-07-29
00757770435401Bausch + LombBausch & Lomb IncorporatedKCP2025-07-29
00757770435999Bausch + LombBausch & Lomb IncorporatedKCP2025-07-29
00757770436620Bausch + LombBausch & Lomb IncorporatedKCP2025-07-29
00757770457588Bausch + LombBausch & Lomb IncorporatedKCP2025-07-29
10661392010441LSL HEALTHCARELSL Industries, LLCKCP2025-05-16
10661392010809LSL HEALTHCARELSL Industries, LLCKCP2025-05-16
10661392013411LSL HEALTHCARELSL Industries, LLCKCP2025-05-16
10661392045399LSL HEALTHCARELSL Industries, LLCKCP2025-05-16
00370275092025FS Dispenser, StainlessForward Science Technologies LLCKCP2024-10-14
EDET031591mixing cannulas optima lilac 50 pcs.DETAX GmbHKCP2024-08-28
EDET031601mixing cannulas optima lilac 100 pcs.DETAX GmbHKCP2024-08-28
EDET041941mixing cannulas Automix 2 T-Mixer yellow 25 pcsDETAX GmbHKCP2024-08-28
00840183511951BR Surgical, LLCBR Surgical, LLCKCP2024-06-10
00840183511968BR Surgical, LLCBR Surgical, LLCKCP2024-06-10
00840183525477BR Surgical, LLCBR Surgical, LLCKCP2024-06-10
00370275091011FS DispenserForward Science Technologies LLCKCP2024-02-21
EDET034481Flexible tube for minimix cannulas, 20 cmDETAX GmbHKCP2024-02-12
00810132804106House Brand DentistryHouse Brand DentistryKCP2024-01-31
EDET032451bulk box mix.cann.optima lila 2500pcsDETAX GmbHKCP2023-12-21
G586E733516S0Novo SurgicalNOVO SURGICAL, INC.KCP2023-12-18
G586E733518S0Novo SurgicalNOVO SURGICAL, INC.KCP2023-12-18
G586E733521S0Novo SurgicalNOVO SURGICAL, INC.KCP2023-12-18
G586E7335270Novo SurgicalNOVO SURGICAL, INC.KCP2023-12-18
G586E97335200Novo SurgicalNOVO SURGICAL, INC.KCP2023-12-18
G586E97335270Novo SurgicalNOVO SURGICAL, INC.KCP2023-12-18