FDA.reportPublic FDA data

Fisherbrand

Primary DI
30613647021270
Brand
Fisherbrand
Company
FISHER SCIENTIFIC COMPANY L.L.C.
Model
22363154
Catalog number
22363154
Device description
FB TNGE DEPSR 6X3/4 NS 500/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
20613647021273PackageGS11In Commercial Distribution
30613647021270PackageGS110In Commercial Distribution
00613647021279PrimaryGS10
10613647021276Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061364702127320613647021273
3061364702127030613647021270
00613647021279006136470212796136470212790613647021279
1061364702127610613647021276

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
500
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
00613647028346Fisherbrand11002204110022042025-06-30
00613647028674Fisherbrand13-711-274MD13711274MD2025-06-30
00613647028681Fisherbrand13-711-336MD13711336MD2025-06-30
00613647028698Fisherbrand13-711-5AMMD137115AMMD2025-06-30
00613647028711Fisherbrand13-711-9AMMD137119AMMD2025-06-30
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
00613647010907FisherbrandSC-150-100135001002025-04-30
00613647010914FisherbrandSC-180-100135001012025-04-30
00613647010921FisherbrandSC-220-100135001022025-04-30
00613647010938FisherbrandSC-250-100135001032025-04-30
00613647018842Fisherbrand23101000231010002025-04-30
00613647018859Fisherbrand23101001231010012025-04-30
00613647018866Fisherbrand23101002231010022025-04-30
00613647018873Fisherbrand23101003231010032025-04-30

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
10810132041188HCSConcordance 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