FDA.reportPublic FDA data

HCS

Primary DI
00849027002105
Brand
HCS
Company
DYAD MEDICAL SOURCING, LLC
Model
HCS2001
Device description
5.5” Tongue Depressor, Junior, Sterile
Published
2019-12-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
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
10849027002102PackageGS110Not in Commercial Distribution
00849027002105PrimaryGS10
20849027002109Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084902700210210849027002102
00849027002105008490270021058490270021050849027002105
2084902700210920849027002109

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.

Regulatory Flags#

DUNS number
078572603
Device count
100
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00849027000149HCSHCS50062017-01-17
00849027000156HCSHCS50072017-01-17
00849027002587HCSHCS5006C2017-01-17
00849027001757HCSHCS11012019-12-31
00849027001764HCSHCS1101C2019-12-31
00849027001771HCSHCS11032019-12-31
00849027001788HCSHCS1103C2019-12-31
00849027001795HCSHCS11042019-12-31
00849027001801HCSHCS11052019-12-31
00849027001818HCSHCS11062019-12-31
00849027002846HCSHCS11022019-12-31
00849027005182HCSHCS11202021-01-31
00849027005199HCSHCS1120C2021-01-31
00849027005205HCSHCS11212021-01-31
00849027005212HCSHCS11222021-01-31
00849027005229HCSHCS1122C2021-01-31
00849027005236HCSHCS11232021-01-31
00849027005243HCSHCS11252021-01-31
00849027001740HCSHCS11002019-12-31
50849027001417HCSHCS3003XL2019-12-31

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Primary DI, Brand, Company table
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30609576700027Puritan®Puritan Medical ProductsFMA2026-07-20
30609576700034Puritan®Puritan Medical ProductsFMA2026-07-20
30609576700041Puritan®Puritan Medical ProductsFMA2026-07-20
30609576700058Puritan®Puritan Medical ProductsFMA2026-07-20
30609576700188Brightwood®Puritan Medical ProductsFMA2026-07-20
00840456200278JMUJMU DENTAL, INCFMA2026-07-10
00840456213605JMUJMU DENTAL, INCFMA2026-07-10
00840456213575JMUJMU DENTAL, INCFMA2026-07-08
00840456213582JMUJMU DENTAL, INCFMA2026-07-08
00840456213599JMUJMU DENTAL, INCFMA2026-07-08
05060212050687Bruenings Tongue Depressor, 190mmDTR MEDICAL LIMITEDFMA2026-06-10
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05010058183605InstrapacROBINSON HEALTHCARE LIMITEDFMA2025-09-11
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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