FDA.reportPublic FDA data

ELMED

Primary DI
00842180173668
Brand
ELMED
Company
ELMED INCORPORATED
Model
30-41-03
Catalog number
30-41-03
Device description
HIRSCHMAN ANOSCOPE 7/8” X 2 3/8”
Published
2023-07-28
Public version status
Update
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
00842180173668PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842180173668008421801736688421801736680842180173668

GMDN Terms#

Term, Definition table
TermDefinition
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 light source and can be viewed by the user through relayed lens optics or direct vision. This device is commonly 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
00198506093876ELMED INCORPORATED9840FS-T9840FS-T2026-08-18
00198506093883ELMED INCORPORATED9841FS-T9841FS-T2026-08-18
00198506093890ELMED INCORPORATED9831FS9831FS2026-08-18
00198506093906ELMED INCORPORATED9835FS9835FS2026-08-18
00198506093913ELMED INCORPORATED9843FS-T9843FS-T2026-08-18
00198506093920ELMED INCORPORATED9844FS-T9844FS-T2026-08-18
00198506093937ELMED INCORPORATEDSTE237820STE2378202026-08-18
00198506093944ELMED INCORPORATEDSTE322424ISTE322424I2026-08-18
00198506093951ELMED INCORPORATED31400-12353HD-OLY31400-12353HD-OLY2026-08-18
00198506093968ELMED INCORPORATED9846FS-T9846FS-T2026-08-18
00198506093975ELMED INCORPORATED25657-1025657-102026-08-18
00198506093982ELMED INCORPORATED22-5200-09F22-5200-09F2026-08-18
00198506093999ELMED INCORPORATEDSTE232825STE2328252026-08-18
00198506094002ELMED INCORPORATED24222-3824222-382026-08-18
00198506094019ELMED INCORPORATED9833FS9833FS2026-08-18
00198506094026ELMED INCORPORATED9842FS-T9842FS-T2026-08-18
00198506094033ELMED INCORPORATED9845FS-T9845FS-T2026-08-18
00198506094040ELMED INCORPORATED9837FS9837FS2026-08-18
00198506094057ELMED INCORPORATEDSTE3230124STE32301242026-08-18
00198506094064ELMED INCORPORATEDSTE6181010STE61810102026-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00850048720732Speculum KitsSpecialty Health Products, LLCFFQ2026-07-23
00850048720541Speculum KitsSpecialty Health Products, LLCFFQ2026-07-22
05055445961107SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961114SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961121SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961138SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961145SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961152SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961169SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961176SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961183SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961190SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961206SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961213SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961220SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961237SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961244SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961251SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961282SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961299SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961305SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961312SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961329SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961336SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12