FDA.reportPublic FDA data

V. Mueller

Primary DI
10885403129995
Brand
V. Mueller
Company
CAREFUSION 2200, INC
Model
SU12
Catalog number
SU12
Device description
HIRSCHMAN ANOSCOPE SMALL DIAMETER 9/16"(1.4CM) WORKING LENGTH 2-3/4"(7CM)
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
10885403129995PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540312999510885403129995

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
832696038
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
50382909101206Surgiphor9101209101202026-03-05
10885403273780PleurX50-007550-00752017-06-12
10885403075964PleurX50-905050-90502017-06-12
50885403075993Denver42-200042-20002017-06-12
50885403076006Denver42-205542-20552017-06-12
50885403076082Denver42-205042-20502017-06-12
10885403051722V. MuellerHY21305HY213052017-08-11
10885403049408V. MuellerGU4050-008GU4050-0082018-08-30
10885403071263V. MuellerNL1350NL13502018-09-05
10885403105159V. MuellerOS5000-002OS5000-0022018-09-10
20885403473170N/A5513E5513E2019-03-25
50885403142176Wet Exidine448944892018-07-18
50885403142183NA442044202018-07-18
50885403142190NA4461A4461A2018-07-18
50885403142220NA4472A4472A2018-07-18
50885403175211NA443744372018-07-18
50885403184473NA446844682018-07-18
50885403184480NA4469A4469A2018-07-18
50885403192829Scrub Care ExidineCLEAN1CLEAN12018-05-02
10885403465154Snowden-PencerSI325SI3252018-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08033638802878Self-light anoscopesSAPI MED SPAFER2026-02-06
00860012876808Air AssistGASTRO CONCEPTS LLCFER2025-03-17
18051887044730THD N-Ano anoscopeTHD SPAFER2025-03-14
18051887044754THD N-Ano AnoscopeTHD SPAFER2025-03-14
08033638801192AdaptorSAPI MED SPAFER2023-08-02
08033638800447Self-light anoscopesSAPI MED SPAFER2023-07-27
08033638803585Self-light anoscopesSAPI MED SPAFER2023-07-27
08033638801260Self-light anoscopesSAPI MED SPAFER2023-07-27
08033638801369EpoflierSAPI MED SPAFER2023-07-27
08033638802892Self-light anoscopesSAPI MED SPAFER2023-07-27
00732094007657Welch Allyn, Inc.WELCH ALLYN, INC.FER2023-04-27
00732094239331Welch Allyn, Inc.WELCH ALLYN, INC.FER2023-04-25
04053755200436INSTRUMENT HEAD FOR UNISPEC TUBESHeine Optotechnik GmbH & Co. KGFER2023-01-11
00732094007626Welch Allyn, Inc.WELCH ALLYN, INC.FER2021-05-07
00732094128208Welch Allyn, Inc.WELCH ALLYN, INC.FER2021-05-07
00732094007664Welch Allyn, Inc.WELCH ALLYN, INC.FER2021-04-26
00732094009828Welch Allyn, Inc.WELCH ALLYN, INC.FER2021-04-26
00732094007541Welch Allyn, Inc.WELCH ALLYN, INC.FER2021-04-15
00732094007602Welch Allyn, Inc.WELCH ALLYN, INC.FER2021-04-15
00732094007633Welch Allyn, Inc.WELCH ALLYN, INC.FER2021-04-15
00732094007640Welch Allyn, Inc.WELCH ALLYN, INC.FER2021-04-15
00732094009736Welch Allyn, Inc.WELCH ALLYN, INC.FER2021-04-15
00732094009743Welch Allyn, Inc.WELCH ALLYN, INC.FER2021-04-15
00732094009750Welch Allyn, Inc.WELCH ALLYN, INC.FER2021-04-15
00732094009767Welch Allyn, Inc.WELCH ALLYN, INC.FER2021-04-15
00732094009774Welch Allyn, Inc.WELCH ALLYN, INC.FER2021-04-15
00732094009804Welch Allyn, Inc.WELCH ALLYN, INC.FER2021-04-15
00732094009811Welch Allyn, Inc.WELCH ALLYN, INC.FER2021-04-15
00732094128178Welch Allyn, Inc.WELCH ALLYN, INC.FER2021-04-15
00732094128222Welch Allyn, Inc.WELCH ALLYN, INC.FER2021-04-15