FDA.reportPublic FDA data

Sani-Scope

Primary DI
50888937013653
Brand
Sani-Scope
Company
Coopersurgical, Inc.
Model
82420
Device description
Sani-Scope® Disposable Anoscope
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
HIBSpeculum, Vaginal, Nonmetal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIBSpeculum, Vaginal, NonmetalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K841909000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K841909000VAGINAL SPECULUM - DISPOSABLEGalenica Enterprises, Inc.1984-07-31HIB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888937013652PackageGS14In Commercial Distribution
50888937013653PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088893701365220888937013652
5088893701365350888937013653

GMDN Terms#

Term, Definition table
TermDefinition
Anoscope, single-useA sterile 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 single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
801895244
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888937027327ER-SpecC0203002026-08-05
00888937027334ER-SpecC0203102026-08-05
00888937027341ER-SpecC0203202026-08-05
00888937027358HER-SpecC0206002026-08-05
00888937027365HER-SpecC0206102026-08-05
00888937027372HER-SpecC0206202026-08-05
00888937027389OfficeSPECC0200012026-08-06
00888937027396HER-SpecC0205002026-08-06
00888937027402HER-SpecC0205102026-08-06
00888937027419HER-SpecC0205202026-08-06
00888937027426ER-SPECC020100-12026-08-06
00888937027433ER-SPECC020110-12026-08-06
00888937027440ER-SpecC020120-12026-08-06
00888937027457ER-SpecC020130-12026-08-06
00888937027464ER-SpecC020140-12026-08-06
00888937027594AnoSPECC0601002026-08-05
00888937027600AnoSPECC0601102026-08-05
00888937027617AnoSPECC0601202026-08-05
00888937032833LifeGlobal® Coda®Incubator UnitGCIU-010-M2026-08-03
00888937032840LifeGlobal® Coda®Filter for Incubator UnitGCIF-001-M2026-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199536930063BluelineTransparent Supply Solutions Ltd.HIB2026-08-07
00199536930070BluelineTransparent Supply Solutions Ltd.HIB2026-08-07
00199536930087BluelineTransparent Supply Solutions Ltd.HIB2026-08-07
00199536930094BluelineTransparent Supply Solutions Ltd.HIB2026-08-07
00199536930100BluelineTransparent Supply Solutions Ltd.HIB2026-08-07
00199536930117BluelineTransparent Supply Solutions Ltd.HIB2026-08-07
00888937027389OfficeSPECCoopersurgical, Inc.HIB2026-08-06
00888937027396HER-SpecCoopersurgical, Inc.HIB2026-08-06
00888937027402HER-SpecCoopersurgical, Inc.HIB2026-08-06
00888937027419HER-SpecCoopersurgical, Inc.HIB2026-08-06
00888937027426ER-SPECCoopersurgical, Inc.HIB2026-08-06
00888937027433ER-SPECCoopersurgical, Inc.HIB2026-08-06
00888937027440ER-SpecCoopersurgical, Inc.HIB2026-08-06
00888937027457ER-SpecCoopersurgical, Inc.HIB2026-08-06
00888937027464ER-SpecCoopersurgical, Inc.HIB2026-08-06
00888937027327ER-SpecCoopersurgical, Inc.HIB2026-08-05
00888937027334ER-SpecCoopersurgical, Inc.HIB2026-08-05
00888937027341ER-SpecCoopersurgical, Inc.HIB2026-08-05
00888937027358HER-SpecCoopersurgical, Inc.HIB2026-08-05
00888937027365HER-SpecCoopersurgical, Inc.HIB2026-08-05
00888937027372HER-SpecCoopersurgical, Inc.HIB2026-08-05
00860015815705Rosa SpeculumMY VILLAGE INNOVATIONS INC.HIB2026-07-20
20860000270421Nella Next Reusable Vaginal SpeculumCEEK WOMEN'S HEALTHHIB2026-06-25
00860000270496Nella Comfort Kit First Time ExamCEEK WOMEN'S HEALTHHIB2026-05-05
00860000270472Nella Comfort Kit Classic RetailCEEK WOMEN'S HEALTHHIB2026-04-15
00860000270489Nella Comfort Kit Curves RetailCEEK WOMEN'S HEALTHHIB2026-04-15
10860008900309ClearSpecClearspec LLCHIB2025-10-29
10860008900316ClearSpecClearspec LLCHIB2025-10-29
10860008900323ClearSpecClearspec LLCHIB2025-10-29
10860008900330ClearSpecClearspec LLCHIB2025-10-29