FDA.reportPublic FDA data

V. Mueller

Primary DI
10885403060946
Brand
V. Mueller
Company
STERIS CORPORATION
Model
SU220
Catalog number
SU220
Device description
V. Mueller FANSLER PROCTOSCOPE OPEN AT TOP DIAMETER 1-1/3 inches 3.3CM WORKING LENGTH 2-3/8 inches 6CM
Published
2018-09-17
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
FFQSPECULUM, RECTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFQSpeculum, RectalGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885403060946PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540306094610885403060946

GMDN Terms#

Term, Definition table
TermDefinition
Proctoscope, reusableAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the rectum and anus. It is inserted into the body through the anus during proctoscopy. Anatomical images are transmitted to the user by the device by direct or magnified viewing. This device is longer than an anoscope to provide a deeper view and it is typically equipped with illumination in the distal end. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-9088Customer_Support@BD.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
00724995023911VERIFYIncubatorS30802021-03-31
00724995023928VERIFYIncubatorS30812021-03-31
00724995023935VERIFYIncubatorS30822021-03-31
00724995095659VERIFYIncubatorS32712021-03-31
00724995301934V. MuellerNL1060NL10602026-10-21
00724995301958V. MuellerNL1064NL10642026-10-21
00724995301972V. MuellerNL1073NL10732026-10-21
00724995301989V. MuellerNL1074NL10742026-10-21
00724995301996V. MuellerNL1075NL10752026-10-21
00724995326906V. MuellerRH1045RH10452026-10-21
00724995239909V. MuellerDP11DP112026-10-15
00724995239916V. MuellerDP12DP122026-10-15
00724995239923V. MuellerDP13DP132026-10-15
00724995239930V. MuellerDP14DP142026-10-15
00724995239947V. MuellerDP15DP152026-10-15
00724995239985V. MuellerED112ED1122026-10-15
00724995239992V. MuellerED15ED152026-10-15
00724995240004V. MuellerED16ED162026-10-15
00724995240011V. MuellerED17ED172026-10-15
00724995240028V. MuellerED19ED192026-10-15

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
00860015748508Thermora AnoscopeOMEC Medical (NV) Inc.FFQ2026-07-31
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