FDA.reportPublic FDA data

ELMED

Primary DI
00198506001284
Brand
ELMED
Company
ELMED INCORPORATED
Model
ST304103M
Catalog number
ST304103M
Device description
HIRSCHMAN ANOSCOPE 7/8” X 2 3/8”, MATTE FINISH
Published
2024-04-24
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
FFQSpeculum, Rectal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFQSpeculum, RectalGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198506001284PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198506001284001985060012841985060012840198506001284

GMDN Terms#

Term, Definition table
TermDefinition
Optical anoscope, reusableAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the anus and rectum. It is inserted into the body through the anus during anoscopy. The inserted portion is short in length, though longer than a sphincteroscope, and large in diameter, and an obturator is typically inserted into its lumen to assist the insertion. The anatomical images are illuminated by a built-in or external light source and can be viewed by the user through relayed lens optics or direct vision. This device is typically used to examine/diagnose patients suffering pain in the rectum/anus, haemorrhoids, or anal fissures. 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
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
B382SD917665100Surgical DirectSurgical Direct, Inc.FFQ2026-10-20
B382SD917665110Surgical DirectSurgical Direct, Inc.FFQ2026-10-20
B382SD917665120Surgical DirectSurgical Direct, Inc.FFQ2026-10-20
B382SD917665700Surgical DirectSurgical Direct, Inc.FFQ2026-10-20
B382SD917665920Surgical DirectSurgical Direct, Inc.FFQ2026-10-20
B382SD917665930Surgical DirectSurgical Direct, Inc.FFQ2026-10-20
00190776433352MillenniumAvalign Technologies, Inc.FFQ2026-10-05
00190776433369MillenniumAvalign Technologies, Inc.FFQ2026-10-05
00190776433376MillenniumAvalign Technologies, Inc.FFQ2026-10-05
00190776433383MillenniumAvalign Technologies, Inc.FFQ2026-10-05
00190776433390MillenniumAvalign Technologies, Inc.FFQ2026-10-05
00190776433406MillenniumAvalign Technologies, Inc.FFQ2026-10-05
00190776433413MillenniumAvalign Technologies, Inc.FFQ2026-10-05
00190776433420MillenniumAvalign Technologies, Inc.FFQ2026-10-05
00190776433437MillenniumAvalign Technologies, Inc.FFQ2026-10-05
00190776433444MillenniumAvalign Technologies, Inc.FFQ2026-10-05
00190776433451MillenniumAvalign Technologies, Inc.FFQ2026-10-05
00190776433468MillenniumAvalign Technologies, Inc.FFQ2026-10-05
00190776433475MillenniumAvalign Technologies, Inc.FFQ2026-10-05
00190776433482MillenniumAvalign Technologies, Inc.FFQ2026-10-05
00190776433499MillenniumAvalign Technologies, Inc.FFQ2026-10-05
00190776433505MillenniumAvalign Technologies, Inc.FFQ2026-10-05
G141554100200Carnegie Surgical LLCCarnegie Surgical LLCFFQ2026-09-30
00190776432362MillenniumAvalign Technologies, Inc.FFQ2026-09-24
00860015748508Thermora AnoscopeOMEC Medical (NV) Inc.FFQ2026-07-31
00190776422189MillenniumAvalign Technologies, Inc.FFQ2026-07-28
00850048720619Speculum KitsSpecialty Health Products, LLCFFQ2026-07-23
00850048720626Speculum KitsSpecialty Health Products, LLCFFQ2026-07-23
00850048720633Speculum KitsSpecialty Health Products, LLCFFQ2026-07-23
00850048720640Speculum KitsSpecialty Health Products, LLCFFQ2026-07-23