FDA.reportPublic FDA data

NA

Primary DI
H98103615004S0
Brand
NA
Company
Synthes GmbH
Model
03.615.004S
Catalog number
03615004S
Device description
LIGHT CLIP-STERILE FOR INSIGHT ACCESS RETRACTOR
Published
2018-10-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FDGRETRACTOR, FIBEROPTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDGRetractor, FiberopticGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07611819419155Direct MarkingGS10
10705034715247PrimaryGS10
H98103615004S0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819419155076118194191557611819419155
1070503471524710705034715247

GMDN Terms#

Term, Definition table
TermDefinition
Fibreoptic operating light systemA system of lights intended to be used in the operating room (OR) to illuminate the surgical site over a prolonged period for optimal visualization of small, low-contrast objects at varying depths or through small incisions. It operates through light provided by a light source, usually located outside of the surgical field, which is delivered through fibreoptic cables to the site of operation. The cables will be mounted, e.g., from the ceiling or attached to a suitable floor mount, or they may possibly connect directly to the surgeons head-worn head light.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
486711679
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982312327NA68.134.011681340112026-10-16
10886982346704VOLT68.134.111681341112026-10-16
10886982346735VOLT68.134.200681342002026-10-16
10886982363282NA68.045.017680450172026-10-16
10886982363299NA68.045.018680450182026-10-16
10886982363305NA68.045.019680450192026-10-16
10886982363312NA68.045.020680450202026-10-16
10705034753690ChronOS07.801.100.99S0780110099S2015-09-14
10705034753706ChronOS07.801.101.99S0780110199S2015-09-14
10705034753713ChronOS07.801.110.99S0780111099S2015-09-14
10705034753720ChronOS07.801.111.99S0780111199S2015-09-14
10705034753737ChronOS07.801.200.99S0780120099S2015-09-14
10705034799933ChronOS710.002.99S71000299S2015-09-14
10705034799940ChronOS710.014.99S71001499S2015-09-14
10705034799957ChronOS710.019.99S71001999S2015-09-14
10705034799964ChronOS710.021.99S71002199S2015-09-14
10705034799971ChronOS710.025.99S71002599S2015-09-14
10705034799988ChronOS710.026.99S71002699S2015-09-14
10705034799995ChronOS710.027.99S71002799S2015-09-14
10705034800004ChronOS710.038.99S71003899S2015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435240MillenniumAvalign Technologies, Inc.FDG2026-10-19
G141572101010Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-10-07
G14157210110Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-10-07
G14157210310Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-10-07
G14157210630Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-10-07
G14157210690Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-10-07
G14157210870Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-10-07
G14157210920Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-10-07
G1415543110400Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-09-30
G14157204210Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-09-30
G14157210130Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-09-30
G14157210200Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-09-30
G141572103590Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-09-30
G14157210570Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-09-30
G14157210590Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-09-30
G14157210670Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-09-30
G141572107270Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-09-30
G14157210830Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-09-30
00840329838867N/ABLACK & BLACK SURGICAL, INC.FDG2026-09-29
G425110676LSI0My MedicalMy Medical Store LLCFDG2026-05-04
G425110686LSI0My MedicalMy Medical Store LLCFDG2026-05-04
00812432023140Medtronic Surgical Illuminator - TubeLumitex, Inc.FDG2026-04-17
00812432023157Medtronic Surgical Illuminator - BladeLumitex, Inc.FDG2026-04-17
00812432023218Lumitex Surgical Tube IlluminatorLumitex, Inc.FDG2026-03-23
G4255721131S0My MedicalMy Medical Store LLCFDG2026-02-27
00812432023133Light Cable, Vaginal RetractorLumitex, Inc.FDG2026-02-11
00812432021559Lumitex MD 3.75mm ACMI Reusable Light CableLumitex, Inc.FDG2026-01-29
00812432023164Medtronic 4mm Universal Reusable Light CableLumitex, Inc.FDG2026-01-07
00812432023171Medtronic 4mm ACMI Cable AdapterLumitex, Inc.FDG2026-01-07
00812432023188Medtronic 4mm WOLF Cable AdapterLumitex, Inc.FDG2026-01-07