FDA.reportPublic FDA data

ELMED

Primary DI
00842180160477
Brand
ELMED
Company
ELMED INCORPORATED
Model
24265-11-OLY2
Catalog number
24265-11-OLY2
Device description
11MM OLYMPUS STYLE THORACIC SLEEVE, SMOOTH, 6.5CM LENGTH
Published
2023-01-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DWSInstruments, Surgical, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842180160477PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842180160477008421801604778421801604770842180160477

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation/aspiration cannula, non-illuminating, reusableAn atraumatic, invasive, hand-operated tube designed as a conduit for irrigation and aspiration (i.e., capable of both functions) of body cavities/wounds during a surgical procedure (e.g., neurosurgery, laparoscopy), typically to facilitate observation. It is not dedicated to dental or intrauterine procedures, not an ophthalmic device, and is not designed to administer parenteral fluids or drugs. It might incorporate a handle with a valve(s) and hole(s) on its side for the control of irrigation/aspiration, and may be provided with a stylet, a sheath, and/or connection tubing; it is typically made of metal. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00198506091667ELMED INCORPORATED32-509-04-I32-509-04-I2026-07-10
00198506091759ELMED INCORPORATED31430-00B31430-00B2026-07-10
00198506091803ELMED INCORPORATEDSTE3220413IVSTE3220413IV2026-07-10
00198506091810ELMED INCORPORATED31960-3131960-312026-07-10
00198506091827ELMED INCORPORATEDSTE321211AISTE321211AI2026-07-10
00198506091834ELMED INCORPORATEDSTE321212AISTE321212AI2026-07-10
00198506091841ELMED INCORPORATED31960-3631960-362026-07-10
00198506091858ELMED INCORPORATED31960-6331960-632026-07-10
00198506091865ELMED INCORPORATED20-2771820-277182026-07-10
00198506091872ELMED INCORPORATED9839FS9839FS2026-07-10
00198506091889ELMED INCORPORATED31560-2131560-212026-07-10
00198506091612ELMED INCORPORATED24129-10B-KW24129-10B-KW2026-06-24
00198506091629ELMED INCORPORATED24129-08B-KW24129-08B-KW2026-06-24
00198506091506ELMED INCORPORATED53020-7853020-782026-06-10
00198506091513ELMED INCORPORATEDSTE3212113ISTE3212113I2026-06-10
00198506091520ELMED INCORPORATEDSTE3212313ISTE3212313I2026-06-10
00198506091537ELMED INCORPORATED32007-1532007-152026-06-10
00198506091544ELMED INCORPORATED32006-1532006-152026-06-10
00198506091551ELMED INCORPORATED23-2503LH23-2503LH2026-06-10
00198506091575ELMED INCORPORATED23-6020-1323-6020-132026-06-10

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03661219510970LANDANGERLANDANGERDWS2026-07-12
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03661219389781DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
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03661219510000DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
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03661219510086DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219511687DELACROIX-CHEVALIERLANDANGERDWS2026-07-04
03661219141440DELACROIX-CHEVALIERLANDANGERDWS2026-06-25
03661219143499DELACROIX-CHEVALIERLANDANGERDWS2026-06-25
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03661219266358DELACROIX-CHEVALIERLANDANGERDWS2026-06-25
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