FDA.reportPublic FDA data

NA

Primary DI
10705034731094
Brand
NA
Company
Synthes GmbH
Model
03.816.700
Catalog number
03816700
Device description
REUSABLE LIGHT
Published
2016-06-30
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
FQPLamp, operating-room

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQPLamp, Operating-RoomGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K993314000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K993314000SYNTHES LIGHT GUIDESynthes (Usa)1999-12-06FQP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07611819583894Direct MarkingGS10
10705034731094PrimaryGS10
H981038167000SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819583894076118195838947611819583894
1070503473109410705034731094

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
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
486711679
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887587060743ChronOS710.000.98S71000098S2015-09-14
10887587060774ChronOS710.003.98S71000398S2015-09-14
10887587060781ChronOS710.011.98S71001198S2015-09-14
10886982228185NA456.456S456456S2015-09-14
10705034717081Zero-P03.617.792036177922015-09-14
10705034717098Zero-P03.617.795036177952015-09-14
10705034717203NA03.617.907036179072015-09-14
10705034722634NA03.804.512S03804512S2019-08-10
10705034731841NA03.820.159S03820159S2019-08-10
10705034736075USS04.607.038046070382015-09-14
10705034742199Zero-P04.617.232S04617232S2015-09-14
10705034754444OPAL08.803.114088031142015-09-14
10705034754468OPAL08.803.116088031162015-09-14
10705034754529OPAL08.803.134088031342015-09-14
10705034754611OPAL08.803.214088032142015-09-14
10705034754635OPAL08.803.216088032162015-09-14
10705034754697OPAL08.803.234088032342015-09-14
10705034754741VERTEBRAL SPACER-TR08.804.037088040372015-09-14
10705034754765VERTEBRAL SPACER-TR08.804.039088040392015-09-14
10705034754826VERTEBRAL SPACER-TR08.804.047088040472015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887761967250Sterilizable HandlesBaxter Medical Systems GmbH + Co. KGFQP2023-07-11
00887761968547Sterilizable HandlesBaxter Medical Systems GmbH + Co. KGFQP2023-07-11
00887761967274Sterilizable HandlesBaxter Medical Systems GmbH + Co. KGFQP2023-06-26
06974539960002SAIKANGJiangsu Saikang Medical Equipment Co.,Ltd.FQP2023-05-31
00887761976450Pre-Install Set Helux ProBaxter Medical Systems GmbH + Co. KGFQP2023-03-07
00887761976474Helux Pro Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-03-07
00887761977334Helux Pro Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-03-07
00887761977341Helux Pro Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-03-07
00887761977358Helux Pro Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-03-07
00887761977365Helux Pro Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-03-07
00887761977389Helux Pro Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-03-07
00887761968479VidiaPortBaxter Medical Systems GmbH + Co. KGFQP2023-01-17
00887761968486VidiaPortBaxter Medical Systems GmbH + Co. KGFQP2023-01-17
00887761968493VidiaPortBaxter Medical Systems GmbH + Co. KGFQP2023-01-17
00887761968325iLED7 Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761970939Carbon SectionsBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761972872Head-Positioning accessoriesBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761972889Head-Positioning accessoriesBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761974432Control UnitsBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761968288iLED7 Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761968295iLED7 Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761968394TL 5000/3000 – Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761968400TL 5000/3000 – Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761968448TL 5000/3000 – Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761972902Head-Positioning accessoriesBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761972926Head-Positioning accessoriesBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761972957Head-Positioning accessoriesBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761968387TL 5000/3000 – Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-01-04
00887761968417TL 5000/3000 – Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-01-04
00887761968127Pre-Install SetBaxter Medical Systems GmbH + Co. KGFQP2022-12-15