FDA.report

ELMED

Primary DI
00198506002007
Brand
ELMED
Company
ELMED INCORPORATED
Model
ST3127056
Catalog number
ST3127056
Device description
Telescope Bridge with 1 Instrument Channel, for Ø 2.7 mm scope
Published
2024-04-24
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
KOASurgical Instruments, G-U, Manual (And Accessories)

Product Code Classifications

CodeDeviceSpecialtyClass
KOASurgical Instruments, G-U, Manual (And Accessories)Gastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00198506002007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00198506002007001985060020071985060020070198506002007

GMDN Terms

TermDefinition
Endoscope sheath, reusableA component of a rigid or flexible endoscope assembly designed as a tube through which an endoscope (e.g., hysteroscope) and endoscopic elements are introduced and assembled to create a complete operative endoscopic unit; it is also designed to function as a protective barrier to isolate the endoscope from patient contact and prevent contamination of the endoscope controls during a procedure. It typically contains ports to enable the insertion of instruments (through the endoscope or through independent working channels), insufflation ports, valves and connectors. It is made of plastic and metal 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
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

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