FDA.reportPublic FDA data

HCS

Primary DI
10810132041188
Brand
HCS
Company
Concordance Healthcare Solutions LLC
Model
HCS2004
Device description
5.5” Tongue Depressor, Junior, Non-Sterile
Published
2023-05-12
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

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
10810132041188PackageGS110In Commercial Distribution
00810132041181PrimaryGS10
20810132041185Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081013204118810810132041188
00810132041181008101320411818101320411810810132041181
2081013204118520810132041185

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
080220245
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
00810132043789HCS9201-5002026-05-13
00810132043796HCS9201-10002026-05-13
00810132044359HCS3004OHCB23004OHCB22026-03-09
00810132044366HCS Sourcing3004OTCB2XL3004OHCB2XL2026-03-09
00810132044335HCS3011SHU3011SHU2026-03-09
00810132044342HCS3011SHXL3011SHXL2026-03-09
10810132044332HCS3011SHU3011SHU2026-03-09
10810132044349HCS3011SHXL3011SHXL2026-03-09
10810132044356HCS3004OHCB22026-03-09
20810132044360HCS Sourcing3004OTCB2XL2026-03-09
10810132043717HCS6605W2026-01-30
10810132043724HCS6606W2026-01-30
00810132040030HCSHCS40032023-04-21
00810132040047HCSHCS40042023-04-21
00810132040979HCSHCS40012023-04-21
00810132040986HCSHCS40022023-04-21
20810132043714HCS6605W2026-01-30
20810132043721HCS6606W2026-01-30
00810132043000HCS818012026-01-23
00810132043017HCS818022026-01-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M2207250003Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.FMA2025-09-11
M220769000Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.FMA2025-09-11
M220770001Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.FMA2025-09-11
05010058083608InstrapacROBINSON HEALTHCARE LIMITEDFMA2025-09-11
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
10080196158744MEDLINEMEDLINE INDUSTRIES, INC.FMA2025-01-17
10080196158768MEDLINEMEDLINE INDUSTRIES, INC.FMA2025-01-17
00887482032756Symmetry WiederASPEN SURGICAL PRODUCTS, INC.FMA2024-08-15
00887482032763Symmetry WiederASPEN SURGICAL PRODUCTS, INC.FMA2024-08-15
00887482049167Symmetry WiederASPEN SURGICAL PRODUCTS, INC.FMA2024-08-15
00887482049174Symmetry WiederASPEN SURGICAL PRODUCTS, INC.FMA2024-08-15
00884392954451Safety 1stDOREL JUVENILE GROUP, INC.FMA2023-10-15
20884392954455Safety 1stDOREL JUVENILE GROUP, INC.FMA2023-10-15
06973069980023Tongue DepressorDalian Rongbang Medical Healthy Devices Co., Ltd.FMA2023-10-04
16973069980020Tongue DepressorDalian Rongbang Medical Healthy Devices Co., Ltd.FMA2023-10-04
00732094082326Welch Allyn, Inc.WELCH ALLYN, INC.FMA2023-08-17
00810132041150HCSConcordance Healthcare Solutions LLCFMA2023-05-12
00810132041167HCSConcordance Healthcare Solutions LLCFMA2023-05-12
00810132041174HCSConcordance Healthcare Solutions LLCFMA2023-05-12
00810132041181HCSConcordance Healthcare Solutions LLCFMA2023-05-12
10810132041157HCSConcordance Healthcare Solutions LLCFMA2023-05-12
10810132041164HCSConcordance Healthcare Solutions LLCFMA2023-05-12
10810132041171HCSConcordance Healthcare Solutions LLCFMA2023-05-12
04053755114603DISPOSABLE TONGUE BLADEHeine Optotechnik GmbH & Co. KGFMA2023-01-11
04053755114771TONGUE BLADE HOLDERHeine Optotechnik GmbH & Co. KGFMA2022-12-12
04053755114788TONGUE BLADE HOLDER DISPOSABLE BLADEHeine Optotechnik GmbH & Co. KGFMA2022-12-12
04053755115129TONGUE BLADE HOLDERHeine Optotechnik GmbH & Co. KGFMA2022-12-12