FDA.report

LSL HEALTHCARE

Primary DI
10661392010809
Brand
LSL HEALTHCARE
Company
LSL Industries, LLC
Model
2301I
Catalog number
2301I
Device description
Piston Irrigation Tray
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

Related Records

Product Codes

CodeName
KCPSYRINGE, ENT

Product Code Classifications

CodeDeviceSpecialtyClass
KCPSyringe, EntEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10661392010809PackageGS120In Commercial Distribution
00661392010802PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1066139201080910661392010809
00661392010802006613920108026613920108020661392010802

GMDN Terms

TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, 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

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

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10661392001913LSL HEALTHCARE7199C7199C2025-05-16
10661392001920LSL HEALTHCARE746174612025-05-16
10661392001999LSL HEALTHCARE750875082025-05-16

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