FDA.reportPublic FDA data

ELMED

Primary DI
00842180167285
Brand
ELMED
Company
ELMED INCORPORATED
Model
24255-05-OLY2
Catalog number
24255-05-OLY2
Device description
5mm, 5.5cm Olympus Style Thoracic Cannula
Published
2023-04-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GJCAssay, Sulfhemoglobin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GJCAssay, SulfhemoglobinHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181173000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181173000ELMED Laparoscopic Instruments and AccessoriesElmed Incorporated2019-03-22GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842180167285PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842180167285008421801672858421801672850842180167285

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic access cannula, reusableA single-lumen surgical device intended to be percutaneously inserted through the abdominal wall to create an access port for a laparoscope/laparoscopic instrument during laparoscopy. The cannula is often provided with a shut-off valve for gas/fluid supply, and other sealing devices (e.g., dedicated seals/rings, caps, valves), to prevent insufflation gas leakage whilst allowing entry of instruments. It may include a sharp or blunt trocar blade to assist introduction and/or puncture the abdominal wall; if the trocar is included it may be referred to as a trocar or trocar assembly. It is available in a variety of dimensions and/or designs. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
224-353-6446medical@elmed.com

Regulatory Flags#

DUNS number
049290364
Device count
1
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842180179219ELMED569556952023-10-05
00198506093876ELMED INCORPORATED9840FS-T9840FS-T2026-08-18
00198506093883ELMED INCORPORATED9841FS-T9841FS-T2026-08-18
00198506093890ELMED INCORPORATED9831FS9831FS2026-08-18
00198506093906ELMED INCORPORATED9835FS9835FS2026-08-18
00198506093913ELMED INCORPORATED9843FS-T9843FS-T2026-08-18
00198506093920ELMED INCORPORATED9844FS-T9844FS-T2026-08-18
00198506093937ELMED INCORPORATEDSTE237820STE2378202026-08-18
00198506093944ELMED INCORPORATEDSTE322424ISTE322424I2026-08-18
00198506093951ELMED INCORPORATED31400-12353HD-OLY31400-12353HD-OLY2026-08-18
00198506093968ELMED INCORPORATED9846FS-T9846FS-T2026-08-18
00198506093975ELMED INCORPORATED25657-1025657-102026-08-18
00198506093982ELMED INCORPORATED22-5200-09F22-5200-09F2026-08-18
00198506093999ELMED INCORPORATEDSTE232825STE2328252026-08-18
00198506094002ELMED INCORPORATED24222-3824222-382026-08-18
00198506094019ELMED INCORPORATED9833FS9833FS2026-08-18
00198506094026ELMED INCORPORATED9842FS-T9842FS-T2026-08-18
00198506094033ELMED INCORPORATED9845FS-T9845FS-T2026-08-18
00198506094040ELMED INCORPORATED9837FS9837FS2026-08-18
00198506094057ELMED INCORPORATEDSTE3230124STE32301242026-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842180198562ELMEDELMED INCORPORATEDGJC2024-04-23
00842180198579ELMEDELMED INCORPORATEDGJC2024-04-23
00842180198623ELMEDELMED INCORPORATEDGJC2024-04-23
00842180198630ELMEDELMED INCORPORATEDGJC2024-04-23
00842180175648ELMEDELMED INCORPORATEDGJC2023-08-08
00842180157699ELMEDELMED INCORPORATEDGJC2023-07-10
00842180167278ELMEDELMED INCORPORATEDGJC2023-04-17
00842180167292ELMEDELMED INCORPORATEDGJC2023-04-17
00190776294892MillenniumAvalign Technologies, Inc.GJC2022-12-12
00190776296629MillenniumAvalign Technologies, Inc.GJC2022-12-12
00192896100831V.A.T.S. FOERSTER CLAMPSONTEC INSTRUMENTS, INC.GJC2020-02-24
04250480107614NASCHÖLLY FIBEROPTIC GmbHGJC2019-02-15
04042761010283OlympusOLYMPUS Winter & Ibe GmbHGJC2016-09-21
00385480420136STAT PROFILENOVA BIOMEDICAL CORPORATIONGJC2016-09-20
00385480420143STAT PROFILENOVA BIOMEDICAL CORPORATIONGJC2016-09-20
00385480420174STAT PROFILENOVA BIOMEDICAL CORPORATIONGJC2016-09-20
00385480420181STAT PROFILENOVA BIOMEDICAL CORPORATIONGJC2016-09-20
00385480485623STAT PROFILENOVA BIOMEDICAL CORPORATIONGJC2016-09-20
00385480485586STAT PROFILENOVA BIOMEDICAL CORPORATIONGJC2016-09-20
00385480485616STAT PROFILENOVA BIOMEDICAL CORPORATIONGJC2016-09-20
00385480485630STAT PROFILENOVA BIOMEDICAL CORPORATIONGJC2016-09-20
00385480485647STAT PROFILENOVA BIOMEDICAL CORPORATIONGJC2016-09-20
00385480485661Stat ProfileNOVA BIOMEDICAL CORPORATIONGJC2016-09-20
00385480485678STAT PROFILENOVA BIOMEDICAL CORPORATIONGJC2016-09-20
00385480485685STAT PROFILENOVA BIOMEDICAL CORPORATIONGJC2016-09-20
00385480485838STAT PROFILENOVA BIOMEDICAL CORPORATIONGJC2016-09-20
00385480485845STAT PROFILENOVA BIOMEDICAL CORPORATIONGJC2016-09-20
00385480485852Stat ProfileNOVA BIOMEDICAL CORPORATIONGJC2016-09-20
00385480485876Stat ProfileNOVA BIOMEDICAL CORPORATIONGJC2016-09-20
00385480485883Stat ProfileNOVA BIOMEDICAL CORPORATIONGJC2016-09-20