FDA.reportPublic FDA data

ELMED

Primary DI
00842180135963
Brand
ELMED
Company
ELMED INCORPORATED
Model
31400-70HD
Catalog number
31400-70HD
Device description
ELMED ENDO URO-SCOPE, 4.0MM DIA., 302MM, HIGH DEFINITION OPTICS, 70 DEGREE
Published
2019-04-15
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
GCMEndoscope, Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCMEndoscope, RigidGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842180135963PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842180135963008421801359638421801359630842180135963

GMDN Terms#

Term, Definition table
TermDefinition
Rigid endoscope telescopeAn optical device designed to provide the illumination and image transmission capabilities of a rigid endoscope. It typically includes a set of lenses (e.g., thin and rod-shaped lenses) and/or a fibreoptic bunch, and is introduced though the sheath of the endoscope (e.g., a rigid cystoscope or resectoscope). The endoscopic telescope is connected proximally to a light source, and the returning image is directly observed or scanned with a video camera. Dedicated types are available for direct, lateral, and oblique views. It is used for examination of body cavities following natural tracts (e.g., urinary, gastrointestinal) or surgical cavities (e.g., laparoscopic). 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
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00198506056529ELMED INCORPORATEDSTT9920FSANSTT9920FSAN2026-10-16
00198506096075ELMED INCORPORATEDSTT9931FSANTSTT9931FSANT2026-10-16
00198506096082ELMED INCORPORATEDSTT9924FSANSTT9924FSAN2026-10-16
00198506096099ELMED INCORPORATEDST9932FSANTSTT9932FSANT2026-10-16
00198506095757ELMED INCORPORATEDST511740ST5117402026-10-09
00198506095764ELMED INCORPORATEDST7162700ST71627002026-10-09
00198506095771ELMED INCORPORATEDST233698ST2336982026-10-09
00198506095788ELMED INCORPORATEDST238248ST2382482026-10-09
00198506095795ELMED INCORPORATEDST365720ST3657202026-10-09
00198506095801ELMED INCORPORATEDST307060ST3070602026-10-09
00198506095818ELMED INCORPORATEDST307061ST3070612026-10-09
00198506095825ELMED INCORPORATEDST307062ST3070622026-10-09
00198506095832ELMED INCORPORATEDST307063ST3070632026-10-09
00198506095849ELMED INCORPORATEDST186403612ST1864036122026-10-09
00198506095856ELMED INCORPORATEDST1580095ST15800952026-10-09
00198506095870ELMED INCORPORATEDST33694-01ST33694-012026-10-09
00198506095887ELMED INCORPORATEDST7141014ST71410142026-10-09
00198506095894ELMED INCORPORATEDST7141015ST71410152026-10-09
00198506095900ELMED INCORPORATEDST7141016ST71410162026-10-09
00198506095917ELMED INCORPORATEDST7141017ST71410172026-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506093951ELMED INCORPORATEDELMED INCORPORATEDGCM2026-08-18
04055207007822NARichard Wolf GmbHGCM2024-08-19
04055207008393NARichard Wolf GmbHGCM2024-08-19
04055207058985NARichard Wolf GmbHGCM2024-08-19
00198506001970ELMEDELMED INCORPORATEDGCM2024-04-24
00198506002137ELMEDELMED INCORPORATEDGCM2024-04-24
00198506002243ELMEDELMED INCORPORATEDGCM2024-04-24
00198506002298ELMEDELMED INCORPORATEDGCM2024-04-24
00198506002311ELMEDELMED INCORPORATEDGCM2024-04-24
00842180187597ELMEDELMED INCORPORATEDGCM2024-04-09
00842180185685ELMEDELMED INCORPORATEDGCM2024-02-20
04053755125999DOUBLE INSUFFLATION BULBHeine Optotechnik GmbH & Co. KGGCM2022-12-12
04055207062890PANOVIEW ULTRARichard Wolf GmbHGCM2021-05-25
04055207062906PANOVIEW ULTRARichard Wolf GmbHGCM2021-05-25
04055207062913PANOVIEW ULTRARichard Wolf GmbHGCM2021-05-25
04055207062920PANOVIEW ULTRARichard Wolf GmbHGCM2021-05-25
04055207062937PANOVIEW ULTRARichard Wolf GmbHGCM2021-05-25
04055207062944PANOVIEW ULTRARichard Wolf GmbHGCM2021-05-25
04042761083485OlympusOLYMPUS Winter & Ibe GmbHGCM2020-07-31
04042761083492OlympusOLYMPUS Winter & Ibe GmbHGCM2020-07-31
04953170393112DVI CABLE 3MOLYMPUS MEDICAL SYSTEMS CORP.GCM2020-05-27
04055207065761NARichard Wolf GmbHGCM2020-05-06
00842180136014ELMEDELMED INCORPORATEDGCM2019-04-30
00842180135970ELMEDELMED INCORPORATEDGCM2019-04-22
00842180135932ELMEDELMED INCORPORATEDGCM2019-04-15
00842180135949ELMEDELMED INCORPORATEDGCM2019-04-15
00842180135956ELMEDELMED INCORPORATEDGCM2019-04-15
04055207011652NARichard Wolf GmbHGCM2017-07-21
04055207058015NARichard Wolf GmbHGCM2017-07-21
04055207058022NARichard Wolf GmbHGCM2017-07-21