FDA.reportPublic FDA data

NA

Primary DI
00724995153083
Brand
NA
Company
BLACK DIAMOND VIDEO, INC.
Model
IDSS-SLC
Catalog number
XQSLC1
Device description
The IDSS-SLC Version 7 OR Integration software module allows the remote control of surgical lights during a surgical procedure.
Published
2017-06-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTALight, surgical, accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTALight, Surgical, AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133413000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133413000IDSS SLCBlack Diamond Video2014-01-07FTA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00724995153083PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995153083007249951530837249951530830724995153083

GMDN Terms#

Term, Definition table
TermDefinition
Operating room audiovisual data/device management system application softwareAn application software program, routines, and/or algorithms intended to be used in an operating room audiovisual data/device management system to enable the system to function according to its intended purpose. The software typically supports remote control of medical and non-medical devices, data management/documentation, and data communication/transfer within and outside of the operating room (OR) [e.g., teleconferencing, teaching/ telesurgery, networking with hospital systems]; it is not intended for long-term storage of patient demographics. It is typically installed into a dedicated integrated network of computers and peripherals.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
556373053
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995245054HexaVueHexaVue FocusXEHFSLC2025-10-17
00724995245061HexaVueHexaVue FocusXEHFSLCAMC2025-10-17
00724995220587HexaVueHexaVue IPXQHPSLC2024-02-08
00724995220594HexaVueHexaVue IPXQHPILCC2024-02-08
00724995198503HexaVueHexaVue SCC 1.0XQHILCC12021-03-31
00724995198497HexaVueHexaVue-SLC 1.0XQHLC12020-09-04
00724995198459FREE5Free5 CameraRLQ1080FCS2021-04-23
00724995209162Uretero1UROSD101UROSD1012022-06-10
00724995209179Uretero1URORD101URORD1012022-06-10
00724995209186Vision1VIS101VIS1012022-06-10
00724995198473NAIDSS-SCCXQSILCC12021-04-23
00724995199135Harmony iQHarmony iQ 2800RLQ2000SLC2021-04-23
00724995199142Harmony iQHarmony iQ 3600RLQ3600SLC2021-04-23
00724995163723NAIDSS-SLC Version 8XQSLC12019-02-28
00724995218799Vividimage W 4KRLM65MG4K3RLM65MG4K32022-08-19
00724995195113Vividimage 4KRLM314K3RLM314K32021-04-23
00724995195137Vividimage 4KRLM314K3NPWRRLM314K3NPWR2021-04-23
00724995195069Vividimage D HDRLM27HD3RLM27HD32021-03-31
00724995195090Vividimage D HDRLM27HD3NPWRRLM27HD3NPWR2021-03-31
00724995195106Vividimage 4KRLM314K2RLM314K22021-03-31

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00748426145027NAMicrotek Medical LLCFTA2026-02-05
20748426262704Medline-MicrotekMicrotek Medical LLCFTA2026-01-05
80080196761844MEDLINEMEDLINE INDUSTRIES, INC.FTA2025-11-04
10724995245457HexaLuxSTERIS CORPORATIONFTA2025-05-05
20885380184113CARDINAL HEALTHCardinal Health 200, LLCFTA2023-12-28
20885380184120CARDINAL HEALTHCardinal Health 200, LLCFTA2023-12-28
20885380184137CARDINAL HEALTHCardinal Health 200, LLCFTA2023-12-28
50885380184787CARDINAL HEALTHCardinal Health 200, LLCFTA2023-12-28
00724995203399NASTERIS CORPORATIONFTA2023-11-17
10197344006915MedlineMEDLINE INDUSTRIES, INC.FTA2023-11-05
50885380183001CARDINAL HEALTHCardinal Health 200, LLCFTA2023-08-11
50885380182998CARDINAL HEALTHCardinal Health 200, LLCFTA2023-08-11
16931918117362AllesetGRI Medical & Electronic Technology Co., Ltd.FTA2023-07-20
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16931918133201AllesetGRI Medical & Electronic Technology Co., Ltd.FTA2022-11-22
16931918196565AllesetGRI Medical & Electronic Technology Co., Ltd.FTA2022-11-22
00748426118526Skytron Lite-LokMicrotek Medical LLCFTA2022-08-08
10193489003093MEDLINE INDUSTRIESMEDLINE INDUSTRIES, INC.FTA2021-11-03
10193489003109MEDLINE INDUSTRIESMEDLINE INDUSTRIES, INC.FTA2021-11-03
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