FDA.reportPublic FDA data

Pac-Dent

Primary DI
10815967020162
Brand
Pac-Dent
Company
PAC-DENT INTERNATIONAL INC
Model
P4550
Published
2016-08-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
PEMDental Barriers And Sleeves

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PEMDental Barriers And SleevesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10815967020162PrimaryGS10
00815967020165Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081596702016210815967020162
00815967020165008159670201658159670201650815967020165

GMDN Terms#

Term, Definition table
TermDefinition
Dental bibA non-sterile device intended to be worn by a patient during a dental examination or treatment procedure to function as a barrier to soiling and cross-contamination. It typically consists of a shaped piece of natural and/or synthetic material intended to be fastened around the neck and cover the front side of the upper body. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
959077454
Device count
10
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10815967020001Pac-Dent1002016-08-26
10815967020032Pac-Dent100B2016-08-26
10815967020049Pac-Dent1012016-08-29
10815967020056Pac-Dent1042016-08-29
10815967020063Pac-Dent101A2016-08-29
10815967020070Pac-Dent1022016-08-29
10815967020087Pac-Dent1032016-08-26
10815967020094Pac-Dent1122016-08-29
10815967020100Pac-Dent1112016-08-26
10815967020117Pac-Dent111SG2016-08-29
10815967020124Pac-Dent1102016-08-26
10815967020131Pac-Dent1092016-08-29
10815967020148Pac-Dent103HP2016-08-29
10815967020155Pac-Dent104HP2016-08-29
10815967020728Pac-DentPPE-248-22016-08-26
10815967022081Pac-DentPE-VI-122016-09-23
10815967022173Pac-DentC1012016-12-27
10815967022180Pac-DentC101B2016-12-27
00815967020424Pac-Dent190LED2016-08-26
00815967020233Pac-DentP37402016-08-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456214459JMUJMU DENTAL, INCPEM2026-07-10
00840456214466JMUJMU DENTAL, INCPEM2026-07-10
00840456214473JMUJMU DENTAL, INCPEM2026-07-10
00840456214480JMUJMU DENTAL, INCPEM2026-07-10
00840456214497JMUJMU DENTAL, INCPEM2026-07-10
00840456214503JMUJMU DENTAL, INCPEM2026-07-10
00840456217931JMUJMU DENTAL, INCPEM2026-07-10
00840456217948JMUJMU DENTAL, INCPEM2026-07-10
00840456217955JMUJMU DENTAL, INCPEM2026-07-10
00840456217962JMUJMU DENTAL, INCPEM2026-07-10
00840456217979JMUJMU DENTAL, INCPEM2026-07-10
00840456217986JMUJMU DENTAL, INCPEM2026-07-10
00840456214305JMUJMU DENTAL, INCPEM2026-07-06
00840456214312JMUJMU DENTAL, INCPEM2026-07-06
00840456214329JMUJMU DENTAL, INCPEM2026-07-06
00840456214336JMUJMU DENTAL, INCPEM2026-07-06
00840456214343JMUJMU DENTAL, INCPEM2026-07-06
00840456214350JMUJMU DENTAL, INCPEM2026-07-06
00840456214367JMUJMU DENTAL, INCPEM2026-07-06
00840456214374JMUJMU DENTAL, INCPEM2026-07-06
00840456214381JMUJMU DENTAL, INCPEM2026-07-06
00840456214398JMUJMU DENTAL, INCPEM2026-07-06
00840456214404JMUJMU DENTAL, INCPEM2026-07-06
00840456214411JMUJMU DENTAL, INCPEM2026-07-06
00840456214428JMUJMU DENTAL, INCPEM2026-07-06
00840456214435JMUJMU DENTAL, INCPEM2026-07-06
00840456214442JMUJMU DENTAL, INCPEM2026-07-06
00840456215265JMUJMU DENTAL, INCPEM2026-07-06
00840456215746JMUJMU DENTAL, INCPEM2026-07-06
00840456217184JMUJMU DENTAL, INCPEM2026-07-06