FDA.reportPublic FDA data

STERLING

Primary DI
00366975063014
Brand
STERLING
Company
BENCO DENTAL SUPPLY CO.
Model
5821-836
Published
2022-08-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00366975063014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00366975063014003669750630143669750630140366975063014

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization packaging, reusableA device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
015108087
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00366975000880MINIBLASTER4696-3222016-09-23
00366975013347FAS-TRACT4006-9062018-12-05
00366975001887BENCO3630-3312016-09-23
D74451864890BENCO5186-4892017-11-29
D74451864980BENCO5186-4982017-11-29
D74451865230BENCO5186-5232017-11-29
D74451865320BENCO5186-5322017-11-29
D74451865410BENCO5186-5412017-11-29
00366975001894BENCO3630-3682016-09-23
00366975001900BENCO3630-3862016-09-23
00366975001917BENCO3630-4022016-09-23
00366975032768BENCO3630-0552016-09-23
00366975070005Sterling5259-5162025-02-26
00366975069993Sterling6694-6422025-02-26
00366975058768BENCO5726-5832022-08-04
00366975003317BENCO3470-4242016-09-23
00366975003409BENCO3470-4152016-09-23
D744101162914Gibson Healthcare1011-6291011-6292015-10-22
D744101164714Gibson Healthcare1011-6471011-6472015-10-22
D74417597511Gibson Healthcare175975117597512017-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10889950157562Hu-FriedyHU-FRIEDY MFG. CO., LLCFSM2026-07-13
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00889929072400NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCFSM2026-07-10
07640177821393Neo Medical Pedicle screw kitNeo Medical SAFSM2026-07-10
07640177821409Neo Medical Pedicle screw kitNeo Medical SAFSM2026-07-10
07640177821416Neo Medical Pedicle screw kitNeo Medical SAFSM2026-07-10
G079IVA22025000Golden Isles Pedicle Screw SystemIntelivation, LLCFSM2026-07-10
G079IVA22026000Golden Isles Pedicle Screw SystemIntelivation, LLCFSM2026-07-10
00840286860086Consensus Knee SystemShalby Advanced Technologies, Inc.FSM2026-07-09
M697X07900081Silex Sacroiliac Joint Fusion SystemXtant Medical Holdings, Inc.FSM2026-07-08
00840456220283JMUJMU DENTAL, INCFSM2026-07-07
00190446907466EF1Medshape, Inc.FSM2026-06-25
00190446907473EF1Medshape, Inc.FSM2026-06-25
00190776421724MillenniumAvalign Technologies, Inc.FSM2026-06-24
00885556924730EVOSSmith & Nephew, Inc.FSM2026-06-24
00840456200308JMUJMU DENTAL, INCFSM2026-06-23
00840456200315JMUJMU DENTAL, INCFSM2026-06-23
00840456201176JMUJMU DENTAL, INCFSM2026-06-23
00840456201206JMUJMU DENTAL, INCFSM2026-06-23
00840456201213JMUJMU DENTAL, INCFSM2026-06-23
00840456201220JMUJMU DENTAL, INCFSM2026-06-23
00840456201237JMUJMU DENTAL, INCFSM2026-06-23
00840456201244JMUJMU DENTAL, INCFSM2026-06-23
00840456201251JMUJMU DENTAL, INCFSM2026-06-23
00840456201268JMUJMU DENTAL, INCFSM2026-06-23
00840456206706JMUJMU DENTAL, INCFSM2026-06-23
00840456206713JMUJMU DENTAL, INCFSM2026-06-23
00840456207000JMUJMU DENTAL, INCFSM2026-06-23
00840456214077JMUJMU DENTAL, INCFSM2026-06-23
00840456214084JMUJMU DENTAL, INCFSM2026-06-23