FDA.reportPublic FDA data

ELMED INCORPORATED

Primary DI
00198506082375
Brand
ELMED INCORPORATED
Company
ELMED INCORPORATED
Model
30-643-02F
Catalog number
30-643-02F
Device description
"Buie-Hirschman Anoscope, Medium, 3/4"" x 3 15/16"", With Fiberoptic and Suction"
Published
2025-04-21
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
00198506082375PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198506082375001985060823751985060823750198506082375

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
00198506091568ELMED INCORPORATED115 515/715115 515/7152026-06-08
00842180148864ELMED INCORPORATED232 412232 4122026-06-08
00198506091414ELMED INCORPORATED52002-92552002-9252026-06-05
00198506091421ELMED INCORPORATED52002-92952002-9292026-06-05
00198506091438ELMED INCORPORATED52002-93352002-9332026-06-05
00198506091445ELMED INCORPORATED24-1951524-195152026-06-05
00198506091452ELMED INCORPORATED51290-30STR51290-30STR2026-06-05
00198506091469ELMED INCORPORATED51290-12STR51290-12STR2026-06-05
00198506091155ELMED INCORPORATED37-5006-10ST37-5006-10ST2026-06-03
00198506091162ELMED INCORPORATED37-1010137-101012026-06-03
00198506091179ELMED INCORPORATEDSTE287850STE2878502026-06-03
00198506091186ELMED INCORPORATED37-013837-01382026-06-03
00198506091193ELMED INCORPORATED37-013937-01392026-06-03
00198506091209ELMED INCORPORATEDSTE1121040STE11210402026-06-03
00198506091216ELMED INCORPORATEDSTE3321924STE33219242026-06-03
00198506091223ELMED INCORPORATED42-242042-24202026-06-03
00198506091230ELMED INCORPORATEDSM13443-21-CRSM13443-21-CR2026-06-03
00198506091247ELMED INCORPORATED52125-7952125-792026-06-03
00198506091254ELMED INCORPORATED52105-61-0552105-61-052026-06-03
00198506091261ELMED INCORPORATED5990M255990M252026-06-03

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05055445961367SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961374SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961381SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961398SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961404SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
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