FDA.report

Dental Bibs

Primary DI
00616784449524
Brand
Dental Bibs
Company
DYNAREX CORPORATION
Model
4495
Device description
Dental Bibs-Lavender 17 3/4"x12 7/8"
Published
2021-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
KHRAbsorber, Saliva, Paper

Product Code Classifications

CodeDeviceSpecialtyClass
KHRAbsorber, Saliva, PaperDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784449531PrimaryGS10
00616784449524Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784449531006167844495316167844495310616784449531
00616784449524006167844495246167844495240616784449524

GMDN Terms

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

Regulatory Flags

DUNS number
008124539
Device count
500
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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00616784710518Sphygmomanometer71052016-09-24
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00616784711423PA [SensiLance Pressure Activated Safety Lancets,Sterile71142021-05-21
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00616784709529Digital Blood Pressure Monitor70952021-01-19
00616784709628Digital Blood Monitors70962021-01-19
00616784709925Blood Pressure Kit,Sphymomanometer with Dual Head Stethoscope70992016-09-24
00616784710020Blood Pressure Kit Sphygmomanometer with Stethoscope71002016-09-24
00616784710228Disposable ECG Snap Electrodes, With Pre-Gelled AG/AGCI Sensor71022016-09-24
00840117344761Resp-O2 Closed Suction Endotracheal Catheter, 8 FR (2.6 mm)310612026-05-25
00840117344778Resp-O2 Closed Suction Endotracheal Catheter, 8 FR (2.6 mm)310622026-05-25
00840117346215Resp-O2 Closed Suction Endotracheal Catheter, 10 FR (3.3 mm)310632026-05-25
00840117349711IV Extension Sets Needle-Free Luer Lock Connector For Injection, Non-Toxic, 17"70612016-09-24
00840117349742IV Extension Sets Needle-Free Luer Lock Connector, Non-Toxic, 8" (20.3 cm)70622016-09-24
00616784706313IV Extension Sets Needle-Free Luer Lock Connector for Injection Non-Toxic70632024-03-25

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Primary DIBrandCompanyProduct codePublished
00810126508201Essentials By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKHR2026-03-12
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00840456201459JMUJMU DENTAL, INCKHR2025-12-11
00840456201466JMUJMU DENTAL, INCKHR2025-12-11
00840456201473JMUJMU DENTAL, INCKHR2025-12-11
00840456201480JMUJMU DENTAL, INCKHR2025-12-11
00840456201497JMUJMU DENTAL, INCKHR2025-12-11
00840456201503JMUJMU DENTAL, INCKHR2025-12-11
00840456201510JMUJMU DENTAL, INCKHR2025-12-11
00840456202753JMUJMU DENTAL, INCKHR2025-12-11
00840456202760JMUJMU DENTAL, INCKHR2025-12-11
00840456202777JMUJMU DENTAL, INCKHR2025-12-11
00840456202784JMUJMU DENTAL, INCKHR2025-12-11
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00840456215159JMUJMU DENTAL, INCKHR2025-12-11
00840456215609JMUJMU DENTAL, INCKHR2025-12-11
00840456215616JMUJMU DENTAL, INCKHR2025-12-11
00840456217191JMUJMU DENTAL, INCKHR2025-12-11
00840456217207JMUJMU DENTAL, INCKHR2025-12-11
00840456217214JMUJMU DENTAL, INCKHR2025-12-11
00840456217221JMUJMU DENTAL, INCKHR2025-12-11
00840456217238JMUJMU DENTAL, INCKHR2025-12-11
00840456217245JMUJMU DENTAL, INCKHR2025-12-11
00840456217252JMUJMU DENTAL, INCKHR2025-12-11
00840456217269JMUJMU DENTAL, INCKHR2025-12-11
00840456217276JMUJMU DENTAL, INCKHR2025-12-11
00840456217283JMUJMU DENTAL, INCKHR2025-12-11
00840456217290JMUJMU DENTAL, INCKHR2025-12-11
00840456217306JMUJMU DENTAL, INCKHR2025-12-11
00840456217313JMUJMU DENTAL, INCKHR2025-12-11