FDA.reportPublic FDA data

Scintillant

Primary DI
10865082000143
Brand
Scintillant
Company
BihlerMed, L.L.C.
Model
2762-01-0003
Device description
Scintillant Dual Bent Tip Surgical Light
Published
2016-08-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTDLamp, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTDLamp, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133425000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133425000SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHTEngineered Medical Solutions Co., LLC2013-12-05FTD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10865082000143PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1086508200014310865082000143

GMDN Terms#

Term, Definition table
TermDefinition
Operating room lightA device designed to provide a specialized source of light for illumination of a site of medical intervention. It provides a high intensity, high colour rendering field of light that minimizes shadows and the emission of heat. It typically consists of an individual light head with more than one light source which may include halogen bulbs or light-emitting diodes (LEDs), reflectors, mirrors and a mechanism to adjust the focus. This device is usually mounted to the ceiling or wall of an operating room (OR) and the mount may be included. It can be part of an OR light system comprising more than one light head.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
908-329-9123contact@bihlermed.com

Regulatory Flags#

DUNS number
828549936
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850009233032BihlerMed2658-01-00022026-01-12
10865082000112Scintillant2658-01-00012016-08-19
10865082000129Scintillant2658-01-00022016-08-19
10865082000136Scintillant2658-01-00042016-08-19
10865082000167Safe-T-Surg2804-01-00012016-08-19
10865082000174SurgiLight Disposable Handle Assembly2816-01-00022019-08-09
10865082000105SurgiLight Adapter - Skytron2816-01-00042019-08-09
20865082000164Safe-T-Surg2804-01-00012016-08-19
20865082000171SurgiLight Disposable Handle Assembly2816-01-00022019-08-09
10865082000198SurgiLight Adapter - Table Mount2816-01-00032019-08-09
10850009233018SurgiLight Adapter - AIM-1002816-01-00092021-06-02
10865082000150Scintillant2762-01-00042016-08-19
10865082000181View Medical SurgiLight2816-01-00012019-08-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10194665008857A-decA-DEC, INC.FTD2026-05-07
10850009233032BihlerMedBihlerMed, L.L.C.FTD2026-01-12
04048675754947PolarisDrägerwerk AG & Co. KGaAFTD2025-11-05
03700712434526Maquet PowerLED IIMAQUET SASFTD2025-09-03
03700712435851Maquet PowerLED IIMAQUET SASFTD2025-09-03
03700712436063Maquet PowerLED IIMAQUET SASFTD2025-09-03
03700712436087Maquet PowerLED IIMAQUET SASFTD2025-09-03
00850036790020AliteRevelle Aesthetics, Inc.FTD2025-09-01
00816744027230Myriad-LXNICO CORPORATIONFTD2025-08-11
00860013851576Nova 3QED, INC.FTD2025-05-22
00860013851507BeamerQED, INC.FTD2025-05-21
00860013851514Nova 300QED, INC.FTD2025-05-21
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08800053093941S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093958S300 SeriesDENTIS CO. ,LTDFTD2025-02-19