FDA.reportPublic FDA data

NA

Primary DI
07613327060331
Brand
NA
Company
STRYKER CORPORATION
Model
0502880201
Catalog number
0502-880-201
Device description
Bridge, Single Horn
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
HIHHYSTEROSCOPE (AND ACCESSORIES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIHHysteroscope (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327060331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327060331076133270603317613327060331

GMDN Terms#

Term, Definition table
TermDefinition
Urethral dilator, reusableA slender, solid or hollow, flexible or semi-flexible, surgical instrument designed to dilate the urethra, mainly to treat strictures of the urethra, to facilitate the extraction of stones (renal calculi), and/or to facilitate catheter placement. It is typically made of metal or plastics and is available in a range of sizes; it may include a mechanical expanding mechanism. The device may also include a dial to show the degree of expansion of the urethra and as such is usually considered a urethrometer. Urethral bougies are also used for urethral dilatation. This is a reusable device.

Sterilization Methods#

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

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
00850006759842Aveta Tissue Catch with TubingMEDITRINA, INC.HIH2026-03-20
16973672291155ARMIJiangsu Jiyuan Medical Technology Co .,Ltd.HIH2026-01-23
16973672291162ARMIJiangsu Jiyuan Medical Technology Co .,Ltd.HIH2026-01-23
16973672291179ARMIJiangsu Jiyuan Medical Technology Co .,Ltd.HIH2026-01-23
16973672291186ARMIJiangsu Jiyuan Medical Technology Co .,Ltd.HIH2026-01-23
06973672291196ARMIJiangsu Jiyuan Medical Technology Co .,Ltd.HIH2026-01-23
00848657077439AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.HIH2025-08-25
00848657077514AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.HIH2025-08-25
00848657077521AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.HIH2025-08-25
00848657077545AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.HIH2025-08-25
00848657077569AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.HIH2025-08-25
26974880991445HTx Disposable HysteroscopeSuzhou AcuVu medical technology Co., Ltd.HIH2025-05-08
26974880991452HTx Disposable HysteroscopeSuzhou AcuVu medical technology Co., Ltd.HIH2025-05-08
06974880991632HTx Disposable HysteroscopeSuzhou AcuVu medical technology Co., Ltd.HIH2025-05-08
26974880993401HTx Disposable HysteroscopeSuzhou AcuVu medical technology Co., Ltd.HIH2025-05-08
04048551274712NAKarl Storz GmbH & Co. KGHIH2025-03-27
04048551274729NAKarl Storz GmbH & Co. KGHIH2025-03-27
04048551274736NAKarl Storz GmbH & Co. KGHIH2025-03-27
04048551367537NAKarl Storz GmbH & Co. KGHIH2025-03-27
04048551418284NAKarl Storz GmbH & Co. KGHIH2025-03-27
00821925002487USA Elite SystemGyrus ACMI, LLCHIH2024-11-27
00821925002104USA Elite SystemGyrus ACMI, LLCHIH2024-11-21
15420045516113Fluent Pro Waste BagHologic, Inc.HIH2024-10-15
15420045516137Fluent Pro Tissue TrapHologic, Inc.HIH2024-10-15
00850006759705Aveta Waste Management AccessoryMEDITRINA, INC.HIH2024-10-14
10850006759733Aveta Waste Bag with Tissue CatchMEDITRINA, INC.HIH2024-10-14
00850033976250HERizon Medical Endoscope Image Processor Minerva Surgical, Inc.HIH2024-10-07
10850033976264HERizon Disposable Electronic HysteroscopeMinerva Surgical, Inc.HIH2024-10-07
04048551390405n.a.Karl Storz GmbH & Co. KGHIH2019-02-23
04048551083451n.a.Karl Storz GmbH & Co. KGHIH2018-08-21