FDA.reportPublic FDA data

Symmetry FANSLER

Primary DI
00887482030318
Brand
Symmetry FANSLER
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
79-5555
Catalog number
79-5555
Device description
Symmetry® Proctoscope; Fansler; 2 1/3 in
Published
2016-05-24
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
GCFProctoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCFProctoscopeGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887482030318PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482030318008874820303188874820303180887482030318

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length2.3333Inch

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 888-364-7004customerservice@symmetrysurgical.com

Regulatory Flags#

DUNS number
027680821
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841785102714Symmetry Olsen20-1040I20-1040I2016-09-09
00841785102769Symmetry Olsen20-106020-10602016-09-06
00841785102776Symmetry Olsen20-1060I20-1060I2016-09-06
00841785102899Symmetry Olsen20-108020-10802016-09-06
00841785102905Symmetry Olsen20-1080I20-1080I2016-09-06
00841785102950Symmetry Olsen20-108220-10822016-09-06
00841785102967Symmetry Olsen20-1082I20-1082I2016-09-06
00841785102974Symmetry Olsen20-1082IMT20-1082IMT2016-09-07
00841785103025Symmetry Olsen20-109020-10902016-09-06
00841785103032Symmetry Olsen20-1090I20-1090I2016-09-06
00841785103049Symmetry Olsen20-1090IMT20-1090IMT2016-09-07
00841785103162Symmetry Olsen20-1162I20-1162I2016-09-06
00841785103285Symmetry Olsen20-1190I20-1190I2016-09-06
00841785103667Symmetry Olsen20-1325I20-1325I2016-09-08
00841785103674Symmetry Olsen20-1325IMT20-1325IMT2016-09-08
00841785103735Symmetry Olsen20-1330I20-1330I2016-09-08
00841785103742Symmetry Olsen20-1330IMT20-1330IMT2016-09-09
00841785103803Symmetry Olsen20-1340I20-1340I2016-09-06
00841785103865Symmetry Olsen20-1350I20-1350I2016-09-06
00841785103988Symmetry Olsen20-1360I20-1360I2016-09-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048551084724n.a.Karl Storz GmbH & Co. KGGCF2018-08-21
04048551265420n.a.Karl Storz GmbH & Co. KGGCF2018-07-21
04048551265437n.a.Karl Storz GmbH & Co. KGGCF2018-07-21
04048551265444n.a.Karl Storz GmbH & Co. KGGCF2018-07-21
04048551265475n.a.Karl Storz GmbH & Co. KGGCF2018-07-21
04048551265499n.a.Karl Storz GmbH & Co. KGGCF2018-07-21
04048551265505n.a.Karl Storz GmbH & Co. KGGCF2018-07-21
04048551314500n.a.Karl Storz GmbH & Co. KGGCF2018-07-21
04048551314524n.a.Karl Storz GmbH & Co. KGGCF2018-07-21
04048551314555n.a.Karl Storz GmbH & Co. KGGCF2018-07-21
04048551229378n.a.Karl Storz GmbH & Co. KGGCF2017-10-20
04048551083307n.a.Karl Storz GmbH & Co. KGGCF2016-09-23
04048551083390RECTOVISIONKarl Storz GmbH & Co. KGGCF2016-09-23
04048551083420RECTOVISIONKarl Storz GmbH & Co. KGGCF2016-09-23
04048551083628RECTOVISIONKarl Storz GmbH & Co. KGGCF2016-09-23
04048551083666RECTOVISIONKarl Storz GmbH & Co. KGGCF2016-09-23
04048551083727TEOKarl Storz GmbH & Co. KGGCF2016-09-23
04048551083741TEOKarl Storz GmbH & Co. KGGCF2016-09-23
04048551083840n.a.Karl Storz GmbH & Co. KGGCF2016-09-23
04048551083888n.a.Karl Storz GmbH & Co. KGGCF2016-09-23
04048551083901n.a.Karl Storz GmbH & Co. KGGCF2016-09-23
04048551083956n.a.Karl Storz GmbH & Co. KGGCF2016-09-23
04048551083970n.a.Karl Storz GmbH & Co. KGGCF2016-09-23
04048551083994n.a.Karl Storz GmbH & Co. KGGCF2016-09-23
04048551084014TEOKarl Storz GmbH & Co. KGGCF2016-09-23
04048551084038TEOKarl Storz GmbH & Co. KGGCF2016-09-23
04048551084090TEOKarl Storz GmbH & Co. KGGCF2016-09-23
04048551084113TEOKarl Storz GmbH & Co. KGGCF2016-09-23
04048551084168n.a.Karl Storz GmbH & Co. KGGCF2016-09-23
04048551084434n.a.Karl Storz GmbH & Co. KGGCF2016-09-23