FDA.reportPublic FDA data

Fisherbrand

Primary DI
30613647021287
Brand
Fisherbrand
Company
FISHER SCIENTIFIC COMPANY L.L.C.
Model
22363155
Catalog number
22363155
Device description
FB TNGE DEPSR 6X3/4 NS 100/PK
Published
2022-12-07
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

Contact Domains#

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
20613647021280PackageGS11In Commercial Distribution
30613647021287PackageGS112In Commercial Distribution
00613647021286PrimaryGS10
10613647021283Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061364702128020613647021280
3061364702128730613647021287
00613647021286006136470212866136470212860613647021286
1061364702128310613647021283

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

Contacts#

Phone, Email table
PhoneEmail
+1(724)517-2425regulatory.affairs@thermofisher.com

Regulatory Flags#

DUNS number
004321519
Device count
100
DM exempt
true
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20613647028340Fisherbrand11002204110022042025-06-30
20613647028678Fisherbrand13-711-274MD13711274MD2025-06-30
20613647028685Fisherbrand13-711-336MD13711336MD2025-06-30
30613647028699Fisherbrand13-711-5AMMD137115AMMD2025-06-30
30613647028712Fisherbrand13-711-9AMMD137119AMMD2025-06-30
00613647029855Fisherbrand121011F2141270512025-06-30
00613647029862Fisherbrand120953F141275542025-06-30
20613647010901FisherbrandSC-150-100135001002025-04-30
20613647010918FisherbrandSC-180-100135001012025-04-30
20613647010925FisherbrandSC-220-100135001022025-04-30
20613647010932FisherbrandSC-250-100135001032025-04-30
20613647018846Fisherbrand23101000231010002025-04-30
20613647018853Fisherbrand23101001231010012025-04-30
20613647018860Fisherbrand23101002231010022025-04-30
20613647018877Fisherbrand23101003231010032025-04-30
20613647018884Fisherbrand23101004231010042025-04-30
20613647018891Fisherbrand23101005231010052025-04-30
20613647024847Fisherbrand19-041-372B19041372B2025-04-30
30613647024851Fisherbrand19-041-372C19041372C2025-04-30
20613647024861Fisherbrand19-041-372D19041372D2025-04-30

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
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
G026090001P&P Medical Surgical LLCP&P Medical Surgical LLCFMA2022-02-11