FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
20885380021111
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
C1565-004
Catalog number
C1565-004
Device description
Tongue Blades, 5 1/2in. L
Published
2019-01-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
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
50885380021112PackageGS110In Commercial Distribution
20885380021111PrimaryGS10
10885380021114Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088538002111250885380021112
2088538002111120885380021111
1088538002111410885380021114

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
961027315
Device count
500
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05010058183605InstrapacROBINSON HEALTHCARE LIMITEDFMA2025-09-11
M220720005Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.FMA2025-09-11
M220769003Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.FMA2025-09-11
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
10810132041164HCSConcordance Healthcare Solutions LLCFMA2023-05-12
10810132041171HCSConcordance Healthcare Solutions LLCFMA2023-05-12
10810132041188HCSConcordance Healthcare Solutions LLCFMA2023-05-12
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