FDA.reportPublic FDA data

NA

Primary DI
07613327063752
Brand
NA
Company
STRYKER CORPORATION
Model
0502880605
Catalog number
0502-880-605
Device description
Urethral Dilator, Curved
Published
2016-09-23
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
FASELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FASElectrode, Electrosurgical, Active, UrologicalGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327063752PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327063752076133270637527613327063752

GMDN Terms#

Term, Definition table
TermDefinition
Rigid endoscope obturatorAn endoscopic device that is a component of a rigid endoscope assembly that has a distally rounded, solid, head or end that is placed into the sheath of a rigid endoscope in order to fill out the sheath's lumen (open end), thereby assisting its insertion into the body and protecting against damage to the patient. This is a reusable device.

Sterilization Methods#

Method table
Method
Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(866)624-4422xx@xx.xx

Regulatory Flags#

DUNS number
187502109
Device count
1
DM exempt
false
Premarket exempt
false
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
07613327687637N/A65170400166517-040-0162026-03-19
07613327687644N/A65170400106517-040-0102026-03-19
07613327687651N/A65170700216517-070-0212026-03-19
07613327687668N/A65170480216517-048-0212026-03-19
07613327687675N/A65170400126517-040-0122026-03-19
07613327628357RPS88080000008808-000-0002025-10-01
07613327656763BPX79000120007900-012-0002026-03-04
07613327656770BPX79000130007900-013-0002026-03-04
07613327657760BPX79000340007900-034-0002026-03-04
07613327657777BPX79000150007900-015-0002026-03-04
07613327657784BPX79000310007900-031-0002026-03-04
07613327657791BPX79000990007900-099-0002026-03-04
07613327657807N/A79003760107900-376-0102026-03-04
07613327657814BPX79000370007900-037-0002026-03-04
07613327657821N/A79003770107900-377-0102026-03-04
07613327657838N/A79003780107900-378-0102026-03-04
07613327659429BPX79000250007900-025-0002026-03-04
37613327693288Malis6760-180-0106760-180-010-Z012026-02-25
37613327693295Malis6760-180-0056760-180-005-Z012026-02-25
37613327693363Malis6760-180-0156760-180-015-Z012026-02-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04049197180757RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFAS2025-07-30
04049197180818RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFAS2025-07-30
04049197393782RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFAS2025-07-30
04049197393812RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFAS2025-07-30
04049197516976RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFAS2025-07-30
04049197517041RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFAS2025-07-30
04049197517058RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFAS2025-07-30
04049197517065RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFAS2025-07-30
04049197517089RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFAS2025-07-30
18904148106336ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-05-03
18904148106350ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-05-03
08904148100849ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
18904148101409ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
18904148101522ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101532ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
18904148101577ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
18904148101584ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101594ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
18904148101607ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
18904148101614ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
18904148101621ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101631ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
18904148101829ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
18904148101836ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
18904148101843ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
18904148101850ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
18904148101867ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
18904148101874ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101884ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
18904148101898ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28