FDA.reportPublic FDA data

V. Mueller

Primary DI
10885403130670
Brand
V. Mueller
Company
STERIS CORPORATION
Model
SU22
Catalog number
SU22
Device description
BUIE-HIRSCHMAN ANOSCOPE SMALL DIAMETER 9/16 inches1.4CM WORKING LENGTH 3-3/4 inches9.5CM
Published
2016-09-24
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
FERAnoscope and accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FERAnoscope And AccessoriesGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885403130670PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540313067010885403130670

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
+1(800)323-9088gmb-MedSpec-CustService@carefusion.com
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
021599373
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995232016NAX-Ray Table TopBF5532026-05-26
00724995232023NAX-Ray Table TopBF5542026-05-26
00724995232030NATable ExtenderBF5552026-05-26
00724995232054NAX-Ray Table TopBF6622026-05-26
00724995232061NAX-Ray Table TopBF6632026-05-26
00724995232078NAX-Ray Table TopBF6642026-05-26
10724995165250NAX-Ray Table TopBF6632021-04-02
10724995165281NAX-Ray Table TopBF6642021-04-02
10724995245457HexaLuxEXLHAN3EXLHAN32025-05-05
00724995165161NAX-Ray Table TopBF5532021-04-02
00724995165178NATable ExtenderBF5552021-04-02
00724995165185NAX-Ray Table TopBF5542021-04-02
00724995165222NAX-Ray Table TopBF6622021-04-02
10885403018862V. MuellerCD0-3BCD03B2017-11-17
10885403018879V. MuellerCD0-3CCD03C2017-11-17
10885403018893V. MuellerCD0-4BCD04B2017-11-17
10885403018909V. MuellerCD0-4CCD04C2017-11-17
10885403018947V. MuellerCD1-4BCD14B2017-11-17
10885403018954V. MuellerCD1-4CCD14C2017-11-17
10885403018985V. MuellerCD1-5BCD15B2017-11-17

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Primary DI, Brand, Company table
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08051887044719THD N-Ano anoscopesTHD SPAFER2025-03-14
08051887044733THD N-Ano anoscopeTHD SPAFER2025-03-14
08051887044757THD N-Ano AnoscopeTHD SPAFER2025-03-14
08051887044771THD N-ano anoscopeTHD SPAFER2025-03-14
18051887044730THD N-Ano anoscopeTHD SPAFER2025-03-14
18051887044754THD N-Ano AnoscopeTHD SPAFER2025-03-14
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08033638800430Self-light anoscopesSAPI MED SPAFER2023-07-27
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08033638801260Self-light anoscopesSAPI MED SPAFER2023-07-27
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