FDA.reportPublic FDA data

Tongue Depressor

Primary DI
00616784431239
Brand
Tongue Depressor
Company
DYNAREX CORPORATION
Model
4312
Device description
Tongue Depressors, Wood, Non-Sterile, Senior, 6"
Published
2021-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
FMADepressor, Tongue, Non-Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMADepressor, Tongue, Non-SurgicalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784431239PackageGS110In Commercial Distribution
00616784431222PrimaryGS10
00616784431215Unit of UseGS10
00810180845137Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784431239006167844312396167844312390616784431239
00616784431222006167844312226167844312220616784431222
00616784431215006167844312156167844312150616784431215
00810180845137008101808451378101808451370810180845137

GMDN Terms#

Term, Definition table
TermDefinition
Tongue depressor, examination, single-useA hand-held device used to displace the tongue to facilitate examination of the surrounding organs/tissues. It is typically a double-ended flat device with rounded working ends made of wood or plastic materials; it may be aromatic/flavoured to make then less intrusive. The device may be used in a healthcare facility, doctor's office, or in the home. This is a single-use device.

Sterilization Methods#

Method table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00616784709734Blood Pressure Cuff Kits, Sphygmomanometer, 3-Cuffs, Child, Adult, Large Adult70972017-11-21
00616784710327Disposable ECG Snap Electrodes, With Pre-Gelled AG/AGCI Sensor71032016-09-24
00616784710518Sphygmomanometer71052016-09-24
00616784710617Sphygmomanometer71062016-09-24
00616784711027Single Head Stethoscope, Single Head71102021-04-22
00616784711126Stethoscope Dual Head71112021-04-22
00616784711225PA SensiLance Pressure Activated Safety Lancets, Sterile71122021-05-21
00616784711423PA [SensiLance Pressure Activated Safety Lancets,Sterile71142021-05-21
00616784709833Blood Pressure Cuff Kits, Sphygmomanometer, 5-Cuffs, Infant, Child, Adult, Large70982017-11-21
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 DI, Brand, Company table
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M220770003Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.FMA2025-09-11
00887482032756Symmetry Surgical®SYMMETRY SURGICAL INC.FMA2024-08-15
00887482032763Symmetry Surgical®SYMMETRY SURGICAL INC.FMA2024-08-15
00887482049167Symmetry Surgical®SYMMETRY SURGICAL INC.FMA2024-08-15
00887482049174Symmetry Surgical®SYMMETRY SURGICAL INC.FMA2024-08-15
20884392954455Safety 1stDOREL JUVENILE GROUP, INC.FMA2023-10-15
16973069980020Tongue DepressorDalian Rongbang Medical Healthy Devices Co., Ltd.FMA2023-10-04
00732094082326Welch Allyn, Inc.WELCH ALLYN, INC.FMA2023-08-17
10810132041157HCSConcordance Healthcare Solutions LLCFMA2023-05-12
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30613647021270FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.FMA2022-12-07
30613647021287FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.FMA2022-12-07
20613647021396FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.FMA2022-12-07
10843471131302DefendYoung Innovations, Inc.FMA2022-10-30
06973069980016DepressorsDalian Rongbang Medical Devices Co.,Ltd.FMA2022-09-07
26973069980010DepressorsDalian Rongbang Medical Devices Co.,Ltd.FMA2022-09-07
50732224003219Tongue DepressorsCROSSTEX INTERNATIONAL, INC.FMA2022-08-19
00192029049396Tongue-Away SheildTP ORTHODONTICS INCFMA2022-05-09
00192029049402Tongue-Away SheildTP ORTHODONTICS INCFMA2022-05-09
00192029049419Tongue-Away SheildTP ORTHODONTICS INCFMA2022-05-09
00192029049426Tongue-Away SheildTP ORTHODONTICS INCFMA2022-05-09
00192029049433Tongue-Away SheildTP ORTHODONTICS INCFMA2022-05-09
00192029049440Tongue-Away SheildTP ORTHODONTICS INCFMA2022-05-09
00192029049457Tongue-Away SheildTP ORTHODONTICS INCFMA2022-05-09
00192029049471Tongue-Away SheildTP ORTHODONTICS INCFMA2022-05-09