FDA.reportPublic FDA data

Black Bibs

Primary DI
00616784449630
Brand
Black Bibs
Company
Dynarex Corporation
Model
4496
Device description
"Black Bibs 17 3/4""x12 7/8"""
Published
2021-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KHRAbsorber, Saliva, Paper

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHRAbsorber, Saliva, PaperDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784449630PrimaryGS10
00810180845434Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784449630006167844496306167844496300616784449630
00810180845434008101808454348101808454340810180845434

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.

Regulatory Flags#

DUNS number
008124539
Device count
500
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117307605Ever-Soft Pommel Gel Foam Cushion 18" x 16" x 3"106852021-04-22
00840117307629Ever-Soft Pommel Gel Foam Cushion 20" x 16" x 3"106862021-04-22
00840117307643Ever-Soft Anti-Thrust Wedge Gel Foam Cushion 18" x 16" x 4" x 2"106902021-04-22
00840117307667Ever-Soft Anti-Thrust Wedge Gel Foam Cushion 20" x 16" x 4" x 2"106912021-04-22
00840117307681Ever-Soft Pommel Wedge Gel Foam Cushion 18" x 16" x 4" x 2"106802021-04-22
00840117307704Ever-Soft Pommel Wedge Gel Foam Cushion 20" x 16" x 4" x 2"106812021-04-22
00840117352476Urinary Drainage Bag Holder 11" x 11" (27.9 cm x 27.9 cm)102612019-10-09
00616784065014Ever-Soft Foam Cushion 16" x 16" x 3"106502021-04-22
00616784065113Ever-Soft Foam Cushion 18" x 16" x 3"106512021-04-22
00616784065212Ever-Soft Foam Cushion 18" x 18" x 3"106522021-04-22
00616784065311Ever-Soft Foam Cushion 20" x 16" x 3"106532021-04-22
00616784065410Ever-Soft Foam Cushion 20" x 18" x 3"106542021-04-22
00840117307568Ever-Soft Coccyx Foam Cushion 18" x 16" x 3"106552021-04-22
00840117307582Ever-Soft Coccyx Foam Cushion 20" x 16" x 3"106562021-04-22
00840117326132Bariatric HD Patient Lift107072023-03-24
00616784067513Ever-Soft Alternating Pressure Air Cushion106752022-05-09
00616784042022DynaRest Multi-Zone Foam Mattress with Perimeter With Perimeter, 36" x 80" x 6"10420P2020-01-15
00616784070414Hydraulic Patient Lift107042019-09-30
00616784070018Electric Patient Lift107002019-09-25
00616784070117Bariatric Electric Patient Lift107012019-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456217696JMUJMU DENTAL, INCKHR2026-06-05
00840456222188JMUJMU DENTAL, INCKHR2026-06-05
00840456222195JMUJMU DENTAL, INCKHR2026-06-05
00840456223000JMUJMU DENTAL, INCKHR2026-06-05
00840456223017JMUJMU DENTAL, INCKHR2026-06-05
00840456201756JMUJMU DENTAL, INCKHR2026-05-27
00840456201763JMUJMU DENTAL, INCKHR2026-05-27
00840456201770JMUJMU DENTAL, INCKHR2026-05-27
00840456201787JMUJMU DENTAL, INCKHR2026-05-27
00840456201794JMUJMU DENTAL, INCKHR2026-05-27
00840456221020JMUJMU DENTAL, INCKHR2026-05-27
10371347011439Advance Dental ProductsThe Atlanta Dental Supply CompanyKHR2024-02-09
10371347011446Advance Dental ProductsThe Atlanta Dental Supply CompanyKHR2024-02-09
10371347011453Advance Dental ProductsThe Atlanta Dental Supply CompanyKHR2024-02-09
10371347011460Advance Dental ProductsThe Atlanta Dental Supply CompanyKHR2024-02-09
10371347011477Advance Dental ProductsThe Atlanta Dental Supply CompanyKHR2024-02-09
10371347011484Advance Dental ProductsThe Atlanta Dental Supply CompanyKHR2024-02-09
10371347011491Advance Dental ProductsThe Atlanta Dental Supply CompanyKHR2024-02-09
10371347011507Advance Dental ProductsThe Atlanta Dental Supply CompanyKHR2024-02-09
50732224004650Econoback TowelsCROSSTEX INTERNATIONAL, INC.KHR2023-07-17
50732224004704Sani-Tab Chain-Free Polyback TowelsCROSSTEX INTERNATIONAL, INC.KHR2023-07-17
50732224004711Sani-Tab Chain-Free Polyback TowelsCROSSTEX INTERNATIONAL, INC.KHR2023-07-17
50732224004728Sani-Tab Chain-Free Polyback TowelsCROSSTEX INTERNATIONAL, INC.KHR2023-07-17
50732224004735Sani-Tab Chain-Free Econoback TowelsCROSSTEX INTERNATIONAL, INC.KHR2023-07-17
50732224004742Sani-Tab Chain-Free Econoback TowelsCROSSTEX INTERNATIONAL, INC.KHR2023-07-17
50732224004759Sani-Tab Chain-Free Econoback TowelsCROSSTEX INTERNATIONAL, INC.KHR2023-07-17
50732224004766Sani-Tab Chain-Free Econoback TowelsCROSSTEX INTERNATIONAL, INC.KHR2023-07-17
50732224004773Professional Regular TowelsCROSSTEX INTERNATIONAL, INC.KHR2023-07-17
50732224004780Professional Regular TowelsCROSSTEX INTERNATIONAL, INC.KHR2023-07-17
50732224004797Professional Regular TowelsCROSSTEX INTERNATIONAL, INC.KHR2023-07-17