FDA.report

ELMED

Primary DI
00842180187382
Brand
ELMED
Company
ELMED INCORPORATED
Model
23-1716
Catalog number
23-1716
Device description
2 PIECE SHUNT PERITONEAL CATHETER PASSER W/ SMALL ROUND T-HANDLE AND FEMALE LUER LOCK, CANNULA: 4.2MM DIA. O.D., 3.6MM DIA. I.D.-60CM WORKING LENGTH, PROBE: 3.5MM DIA. AT TIP, 62CM WORKING LENGTH, REUSABLE STAINLESS STEEL, 64CM OVERALL LENGTH - HOFFMAN STYLE
Published
2024-03-06
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
PIYStainless Steel Instrument, Shunt System Implantation

Product Code Classifications

CodeDeviceSpecialtyClass
PIYStainless Steel Instrument, Shunt System ImplantationNeurology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842180187382PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842180187382008421801873828421801873820842180187382

GMDN Terms

TermDefinition
Vascular dilator, reusableA hand-held surgical instrument designed for insertion into a blood vessel (the vasculature) to unblock, enlarge or measure the internal diameter of the vessel during a surgical intervention. It is a rod-like device with a long, slender, body that terminates with a bulbous, cylindrical distal tip of various shapes and sizes. Commonly known as a vessel dilator or vascular probe, it is available in a variety of sizes (diameters and lengths) and flexibilities. It is typically made of metal or plastic materials. 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
false
Premarket exempt
false
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

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