FDA.report

ELMED

Primary DI
00842180169265
Brand
ELMED
Company
ELMED INCORPORATED
Model
52900-01-10
Catalog number
52900-01-10
Device description
REUSABLE SILICONE VALVE FOR "LITE" TROCAR SLEEVE - 3, 4, 5, 6MM DIA., AUTOCLAVABLE (PKG 10)
Published
2023-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
MNLAccessories, Cleaning Brushes, For Endoscope

Product Code Classifications

CodeDeviceSpecialtyClass
MNLAccessories, Cleaning Brushes, For EndoscopeGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842180169265PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842180169265008421801692658421801692650842180169265

GMDN Terms

TermDefinition
Laparoscopic surgical procedure kit, non-medicated, reusableA collection of various laparoscopic and surgical instruments (e.g., access cannulae, irrigation/aspiration cannula, 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 reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
224-353-6446medical@elmed.com

Regulatory Flags

DUNS number
049290364
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00198506090967ELMED INCORPORATED37120-3537120-352026-05-26
00198506090974ELMED INCORPORATEDSTE36101ESTE36101E2026-05-26
00198506090981ELMED INCORPORATEDSTE3641ESTE3641E2026-05-26
00198506090998ELMED INCORPORATEDSTE245013STE2450132026-05-26
00198506091001ELMED INCORPORATEDSTE245014STE2450142026-05-26
00198506091018ELMED INCORPORATEDSTE245015STE2450152026-05-26
00198506091025ELMED INCORPORATEDSTE245016STE2450162026-05-26
00198506091032ELMED INCORPORATEDSTE245017STE2450172026-05-26
00198506091049ELMED INCORPORATEDSTE245018STE2450182026-05-26
00198506091056ELMED INCORPORATEDSTE245019STE2450192026-05-26
00198506091063ELMED INCORPORATEDSTE245020STE2450202026-05-26
00198506091070ELMED INCORPORATEDSTE245021STE2450212026-05-26
00198506091087ELMED INCORPORATEDSTE245022STE2450222026-05-26
00198506091100ELMED INCORPORATEDSTE322924ISTE322924I2026-05-26
00198506091117ELMED INCORPORATEDSTE322923ISTE322923I2026-05-26
00198506091124ELMED INCORPORATEDSTE3211221ESTE3211221E2026-05-26
00198506089763ELMED INCORPORATED52460-01-H52460-01-H2026-03-24
00198506089770ELMED INCORPORATED52460-02-H52460-02-H2026-03-24
00198506089787ELMED INCORPORATED52460-03-H52460-03-H2026-03-24
00198506089756ELMED INCORPORATED42-191042-19102026-03-23

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06970057578248Disposable Cleaning BrushJiangsu Vedkang Medical Science and Technology Co.,Ltd.MNL2026-05-22
00724995233327DuoswiftUS EndoscopyMNL2026-03-12
00817169024989Pristine by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCMNL2026-03-05
10850075039002Venturi DryGI SCIENTIFIC LLCMNL2026-02-10
10850075039033Venturi DryGI SCIENTIFIC LLCMNL2026-02-10
10850075039057Venturi DryGI SCIENTIFIC LLCMNL2026-02-10
10850075039071Venturi DryGI SCIENTIFIC LLCMNL2026-02-10
10850075039095Venturi DryGI SCIENTIFIC LLCMNL2026-02-10
10850075039118Venturi DryGI SCIENTIFIC LLCMNL2026-02-10
10850075039125Venturi DryGI SCIENTIFIC LLCMNL2026-02-10
10850075039156Venturi DryGI SCIENTIFIC LLCMNL2026-02-10
10850075039194Venturi CleanGI SCIENTIFIC LLCMNL2026-02-10
10850075039217Venturi CleanGI SCIENTIFIC LLCMNL2026-02-10
10860002853106Venturi CleanGI SCIENTIFIC LLCMNL2026-02-10
00860002853192Venturi MicroDryerGI SCIENTIFIC LLCMNL2026-02-10
10860007020909Venturi CleanGI SCIENTIFIC LLCMNL2026-02-10
10860007020947Venturi CleanGI SCIENTIFIC LLCMNL2026-02-10
20860007020968Venturi DryGI SCIENTIFIC LLCMNL2026-02-10
00860007020971Venturi DryGI SCIENTIFIC LLCMNL2026-02-10
10850075039149Venturi DryGI SCIENTIFIC LLCMNL2026-02-09
00190776415686MillenniumAvalign Technologies, Inc.MNL2026-02-04
00198506087370ELMED INCORPORATEDELMED INCORPORATEDMNL2026-01-07
G4533352003290PEAK MEDICALPeak Medical Distribution Inc.MNL2026-01-05
G4533353003310PEAK MEDICALPeak Medical Distribution Inc.MNL2026-01-05
00850067560227LaproClearSurgical Principals, IncMNL2025-12-11
00816185001165AquaBrush SystemTorvan Medical IncMNL2025-12-08
16936603228934Single Use Angulation Knob ExtenderYangzhou Fartley Medical Instrument Technology Co., LtdMNL2025-12-03
16936603231736Single-Use ErgoGrip Knob ExtenderYangzhou Fartley Medical Instrument Technology Co., LtdMNL2025-12-03
00198506018268ELMED INCORPORATEDELMED INCORPORATEDMNL2025-09-05
00198506084775ELMED INCORPORATEDELMED INCORPORATEDMNL2025-08-26