FDA.report

MEDICOM SAFEBASICS

Primary DI
20686864048385
Brand
MEDICOM SAFEBASICS
Company
AMD Medicom Inc
Model
40007
Catalog number
40007
Device description
MEDICOM SAFEBASICS TONGUE DEPRESSORS 6 inch
Published
2019-01-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FMADEPRESSOR, TONGUE, NON-SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
FMADepressor, Tongue, Non-SurgicalGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
12686864048386PackageGS1100Not in Commercial Distribution
20686864048385PackageGS110In Commercial Distribution
30686864048382PackageGS1100In Commercial Distribution
10686864048388PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1268686404838612686864048386
2068686404838520686864048385
3068686404838230686864048382
1068686404838810686864048388

GMDN Terms

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.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Room temperature
Storage Environment Humidity080 Percent (%) Relative Humidity

Sterilization Methods

Method

Contacts

PhoneEmail
+1(514)636-6262mkansou@medicom.ca

Regulatory Flags

DUNS number
256880576
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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20686864060950MEDICOM DENTICARE 10068100682026-02-25
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20686864061650MEDICOM224415.001224415.0012025-11-20
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20686864061469Medicom SafeBasics2101-CHUS2101-CHUS2025-05-13
20686864061476AMD-RitmedA2100-CHUSA2100-CHUS2025-05-13
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20686864061384Medicom AssureTouch9940-B9940-B2025-04-24
00686864061397Medicom AssureTouch9940-C9940-C2025-04-24
20686864061407Medicom AssureTouch9940-D9940-D2025-04-24
00686864061410Medicom AssureTouch9940-E9940-E2025-04-24

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