FDA.reportPublic FDA data

N/A

Primary DI
07613327462746
Brand
N/A
Company
STRYKER CORPORATION
Model
0233035100
Catalog number
0233035100
Device description
Universal Fiber Optic Cable
Published
2020-09-04
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
FCWLight source, fiberoptic, routine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCWLight Source, Fiberoptic, RoutineGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327462746PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327462746076133274627467613327462746

GMDN Terms#

Term, Definition table
TermDefinition
Fibreoptic light cableA flexible fibreoptic cable that is designed to transport cold light from a light source to an instrument or other equipment, e.g., an endoscope or a headlight. The fibreoptic bundle is protected within a sheath and can be made of either glass or plastic fibres. Each end of the cable is encased in a metal connector that fits into the respective instruments/equipment and also protects the end of the fibreoptic bundle. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length3.05Meter
Lumen/Inner Diameter3.5Millimeter

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Hydrogen Peroxide""]"
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
Premarket exempt
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327652703N/A72000152707200-015-2702026-04-15
07613327652710PROstep72000150437200-015-0432026-04-13
07613327652727N/A72010157107201-015-7102026-04-13
07613327652734N/A72000153707200-015-3702026-04-13
07613154599127NA59200002045920-000-2042018-09-24
07613327413281Connected OR Hub02402001000240-200-1002023-07-26
07613327051674AIM SafeLight02330503000233-050-3002016-09-23
07613327056167SDC3024006010102400601012016-09-23
07613327056174SDC3024006010202400601022016-09-23
07613327382389168816880201221688-020-1222019-01-17
07613327405910Precision IE 4K0502-444-0700502-444-0702019-01-21
07613327405927Precision IE 4K0502-445-0300502-445-0302019-01-21
07613327405934Precision IE 4K0502-444-0100502-444-0102019-01-21
07613327405941Precision IE 4K0502-445-0700502-445-0702019-01-21
07613327405958Precision IE 4K0502-444-0300502-444-0302019-01-21
07613327405965Precision IE 4K0502-445-0100502-445-0102019-01-21
07613327405972Precision IE 4K0502-444-0450502-444-0452019-01-21
07613327405989Precision IE 4K0502-444-1300502-444-1302019-01-21
07613327416299Precision IE 4K0502-194-0100502-194-0102019-01-21
07613327416305Precision IE 4K0502-194-0300502-194-0302019-01-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04049047788607GimmiGimmi GmbHFCW2026-03-04
04250480104262N/ASCHÖLLY FIBEROPTIC GmbHFCW2025-06-11
00855373008029StrykerSUNOPTIC TECHNOLOGIES LLCFCW2025-05-15
04049047788522GimmiGimmi GmbHFCW2025-03-20
04048551366813n.a.Karl Storz GmbH & Co. KGFCW2024-11-28
00840183528577BR Surgical, LLCBR Surgical, LLCFCW2024-10-24
04049197465007RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFCW2024-09-20
04049197465069RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFCW2024-09-20
00840183507763BR Surgical, LLCBR Surgical, LLCFCW2024-07-22
00840183527341BR Surgical, LLCBR Surgical, LLCFCW2024-07-22
04250480109045N/ASCHÖLLY FIBEROPTIC GmbHFCW2023-10-24
04961333071333PENTAXHOYA CORPORATIONFCW2023-07-31
04961333238088PENTAXHOYA CORPORATIONFCW2023-07-31
M678SLSS0Sunoptic Surgical, CUDA, Sunoptic Technologies, OEM CustomerSUNOPTIC TECHNOLOGIES LLCFCW2023-03-01
00840319710616Hayden MedicalHayden Medical, Inc.FCW2022-07-28
00840319710623Hayden MedicalHayden Medical, Inc.FCW2022-07-28
00840319710630Hayden MedicalHayden Medical, Inc.FCW2022-07-28
00840319710647Hayden MedicalHayden Medical, Inc.FCW2022-07-28
00840319710654Hayden MedicalHayden Medical, Inc.FCW2022-07-28
00840319710661Hayden MedicalHayden Medical, Inc.FCW2022-07-28
00840319710678Hayden MedicalHayden Medical, Inc.FCW2022-07-28
00840319710685Hayden MedicalHayden Medical, Inc.FCW2022-07-28
00840319710692Hayden MedicalHayden Medical, Inc.FCW2022-07-28
G043MLGA4X7AC0BEARBear-Ent, LLCFCW2022-05-19
G043MLGA4X7ST0BEARBear-Ent, LLCFCW2022-05-19
G043MLGO4X7AC0BEARBear-Ent, LLCFCW2022-05-19
G043MLGO4X7ST0BEARBear-Ent, LLCFCW2022-05-19
G043MLGS4X7AC0BEARBear-Ent, LLCFCW2022-05-19
G043MLGS4X7ST0BEARBear-Ent, LLCFCW2022-05-19
07613327051568NASTRYKER CORPORATIONFCW2021-07-07