FDA.reportPublic FDA data

Thermora Anoscope

Primary DI
00860015748508
Brand
Thermora Anoscope
Company
OMEC Medical (NV) Inc.
Model
ANOS2501-10P-US
Published
2026-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

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
00860015748515PackageGS14In Commercial Distribution
10860015748505PackageGS15In Commercial Distribution
00860015748508PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860015748515008600157485158600157485150860015748515
1086001574850510860015748505
00860015748508008600157485088600157485080860015748508

GMDN Terms#

Term, Definition table
TermDefinition
Optical anoscope, single-useAn 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 single-use device.

Regulatory Flags#

DUNS number
093458455
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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