FDA.report

Sprague Rappaport Stethoscope

Primary DI
00616784713632
Brand
Sprague Rappaport Stethoscope
Company
DYNAREX CORPORATION
Model
7136
Device description
Blue Sprague Rappaport Stethoscope
Published
2021-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
LDEStethoscope, Manual

Product Code Classifications

CodeDeviceSpecialtyClass
LDEStethoscope, ManualCardiovascular1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784713632PackageGS124In Commercial Distribution
00616784713625PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784713632006167847136326167847136320616784713632
00616784713625006167847136256167847136250616784713625

GMDN Terms

TermDefinition
Foetal stethoscopeA mechanical listening device that is used for listening to foetal heart sounds. It is typically designed as a hollow tube (trumpet-shaped) to transmit the foetal heart sound through the inner channel by air conduction and is pressed against the outside of the mother's abdomen and the user will place their head and ear to the listening end of the device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
Device count
1
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
true
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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