FDA.reportPublic FDA data

Symmetry Dittel

Primary DI
00887482075517
Brand
Symmetry Dittel
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
51-6206
Catalog number
51-6206
Device description
Ultra Instruments® Sound, Dittel Surgical Urethral, Curved, 6 Fr
Published
2024-08-12
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
FBXSound, Urethral, Metal Or Plastic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FBXSound, Urethral, Metal Or PlasticGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887482075517PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482075517008874820755178874820755170887482075517

GMDN Terms#

Term, Definition table
TermDefinition
Uterine sound, reusableA hand-held manual instrument designed to measure and/or explore the internal depth or length of the uterus, cervix, and/or vagina. It is a slender hollow or solid cylindrical instrument made of metal or plastic typically with graduations of length displayed along its working end. It is typically available in a range of sizes and flexibilities. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge6French

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-888-364-7004customerservice@symmetrysurgical.com
+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
00841785112812Symmetry Olsen08-0089I08-0089I2018-05-22
00841785113321Symmetry Olsen08-009008-00902018-08-22
00887482139806Symmetry Malis®08-0089I08-0089I2016-05-24
00887482139820Symmetry Malis®08-009008-00902016-05-24
00841785112539Symmetry Olsen08-004508-00452017-11-02
00841785112805Symmetry Olsen08-008908-00892018-05-22
00841785113338Symmetry Olsen08-0047I08-0047I2018-08-22
00887482139547Symmetry Semkin08-004508-00452016-05-04
00887482139561Symmetry Hardy™08-0047I08-0047I2016-05-26
00887482139578Symmetry Surgical08-004808-00482016-05-26
00887482139653Symmetry Surgical08-005908-00592016-05-26
00887482139790Symmetry Malis®08-008908-00892016-05-17
00841785112317Symmetry Olsen08-0000I08-0000I2017-11-02
00841785112331Symmetry Olsen08-000108-00012017-11-02
00841785112348Symmetry Olsen08-0001I08-0001I2017-11-02
00841785112355Symmetry Olsen08-000408-00042017-11-02
00841785112362Symmetry Olsen08-0004I08-0004I2017-11-02
00841785112379Symmetry Olsen08-000508-00052017-11-02
00841785112393Symmetry Olsen08-000708-00072017-11-02
00841785112423Symmetry Olsen08-000908-00092017-11-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10381780509356Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-10-23
10381780500025Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500032Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500049Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500056Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500063Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500070Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500087Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500094Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500100Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500117Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500124Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500131Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500148Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500155Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500162Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500179Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500186Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500193Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500209Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500216Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500223Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500230Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500247Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500254Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500261Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500278Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500285Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500292Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500308Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18