FDA.reportPublic FDA data

Welch Allyn, Inc.

Primary DI
00732094082326
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901025
Catalog number
28100
Device description
Welch Allyn 3.5 V Halogen HPX Tongue-Blade Holder; Power Handle Not Included
Published
2023-08-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00732094082326PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094082326007320940823267320940823260732094082326

GMDN Terms#

Term, Definition table
TermDefinition
Rigid intubation laryngoscope, reusableA hand-held device intended to be used by anaesthesia/emergency service personnel to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation. It has a handle containing batteries to power its light (a small built-in light bulb or fibreoptic light) for airway illumination, and a curved or straight blade of various designs and lengths that can be hinged/interchanged or integral. Some types can be magnetic resonance imaging (MRI) compatible. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(315)685-2834GDSN_SUPPORT@MYHILLROM.ONMICROSOFT.COM

Regulatory Flags#

DUNS number
198227881
Device count
1
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
true
Expiration date on label
false
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
00732094055245Welch Allyn, Inc.901001SM25512026-03-06
00887761976283Life2000MS-01-01252026-02-09
00887761978041Life2000MS-01-01212026-02-09
00732094360363Welch Allyn, Inc.901144QS-6AA-AEAAA2026-02-03
00732094360370Welch Allyn, Inc.901144XSCRIBE-6AA-ACAAA2026-02-03
00732094360295Welch Allyn, Inc.901204 v7.4.2E100012025-12-18
00732094357929Welch Allyn, Inc.90102671-XM2LXE2025-11-25
00732094358933Welch Allyn, Inc.901203C360KIT95RXTBWLJBP2025-11-24
00732094358957Welch Allyn, Inc.901203C360KIT95MXTBWLJBP2025-11-24
00732094358971Welch Allyn, Inc.901203C360KIT95CXTBWLJBP2025-11-24
00732094358988Welch Allyn, Inc.901203C360KIT95CXTBMBJX2025-11-24
00732094237740Welch Allyn, Inc.901049CP150A2025-09-22
00732094356366Welch Allyn, Inc.9010069293-046-572025-09-22
00732094356373Welch Allyn, Inc.9010069293-046-552025-09-22
00732094356380Welch Allyn, Inc.9010069293-046-062025-09-22
00732094356397Welch Allyn, Inc.9010069293-046-052025-09-22
00732094356403Welch Allyn, Inc.9010069293-046-042025-09-22
00732094356410Welch Allyn, Inc.9010069293-046-032025-09-22
00732094309225Welch Allyn, Inc.90105744XT2021-04-26
06932825304237Welch Allyn, Inc.9011232000 PLUS-A2025-08-08

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00887482049174Symmetry Surgical®SYMMETRY SURGICAL INC.FMA2024-08-15
20884392954455Safety 1stDOREL JUVENILE GROUP, INC.FMA2023-10-15
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10810132041157HCSConcordance Healthcare Solutions LLCFMA2023-05-12
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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
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