FDA.reportPublic FDA data

Scintillant

Primary DI
10865082000136
Brand
Scintillant
Company
BihlerMed, L.L.C.
Model
2658-01-0004
Device description
Scintillant Surgical Light with Retractor
Published
2016-08-19
Public version status
Update
Distribution status
Not 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
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTDLamp, SurgicalGeneral, Plastic Surgery2
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20865082000133PackageGS15Not in Commercial Distribution
10865082000136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2086508200013320865082000133
1086508200013610865082000136

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retractor/retraction system blade, reusableA distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge to separate the margins of a wound/incision during a surgical procedure. It is intended to be attached to the frame (e.g., mounting ring/bar) of a surgical retraction system, or may be fixed onto a retractor handle; it does not include a handle. It is a metal device, sometimes referred to as a variable or vario retractor blade when assembled with a separate retractor handle, because it is available in a variety of lengths and sizes. This is a reusable device.

Contacts#

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

Regulatory Flags#

DUNS number
828549936
Device count
1
Kit
true
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
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
10865082000143Scintillant2762-01-00032016-08-19
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
00810168190471NAPACIFIC INSTRUMENTS, INC.GAD2026-07-09
00888937033663ONETRAC™Coopersurgical, Inc.GAD2026-07-09
00888937033670ONETRAC™Coopersurgical, Inc.GAD2026-07-09
00841536148473ThompsonThompson Surgical Instruments, Inc.GAD2026-07-08
00850083275341Intrace USAPILOTIS TECH LLCGAD2026-07-03
00850083275570Intrace USAPILOTIS TECH LLCGAD2026-07-03
00850083275969Intrace USAPILOTIS TECH LLCGAD2026-07-03
B8035202680ORTHOMEDORTHO-MED, INC.GAD2026-06-26
00190776421748MillenniumAvalign Technologies, Inc.GAD2026-06-24
00190776421809MillenniumAvalign Technologies, Inc.GAD2026-06-24
00190776421816MillenniumAvalign Technologies, Inc.GAD2026-06-24
00190776421830MillenniumAvalign Technologies, Inc.GAD2026-06-24
00192896123540Green RetractorSONTEC INSTRUMENTS, INC.GAD2026-06-24
00810220800447Adler Instrument CompanyAdler, Inc.GAD2026-06-24
00190776421649MillenniumAvalign Technologies, Inc.GAD2026-06-23
00190776421670MillenniumAvalign Technologies, Inc.GAD2026-06-23
00810158211292PRINCETONPrinceton Medical Group, Inc.GAD2026-06-23
00348783011456Premier Sawyer RetractorPREMIER DENTAL PRODUCTS COMPANYGAD2026-06-10
00348783011463Premier Sawyer RetractorPREMIER DENTAL PRODUCTS COMPANYGAD2026-06-10
008401944956533P Small-Mini Frag SystemORTHOPEDIATRICS CORP.GAD2026-06-10
008401944956603P Small-Mini Frag SystemORTHOPEDIATRICS CORP.GAD2026-06-10
008401944956773P Small-Mini Frag SystemORTHOPEDIATRICS CORP.GAD2026-06-10
008401944956843P Small-Mini Frag SystemORTHOPEDIATRICS CORP.GAD2026-06-10
05060212055323Silicone Bands 2.16mm x 110mm dia x 3DTR MEDICAL LIMITEDGAD2026-06-10
00198506091339ELMED INCORPORATEDELMED INCORPORATEDGAD2026-06-09
00840277133670Innomed, Inc.INNOMED, INC.GAD2026-06-09
04049047155324GimmiGimmi GmbHGAD2026-06-08
G453PM1580030BC0PEAK MEDICALPeak Medical Distribution Inc.GAD2026-06-08
00846159040524SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040531SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04