FDA.report

AMD-RITMED

Primary DI
20686864041584
Brand
AMD-RITMED
Company
AMD Medicom Inc
Model
1004
Catalog number
1004
Device description
AMD-RITMED NEURO SPONGE DOUBLE STRUNG X-R DETECTABLE 1 X 3 Inch
Published
2019-01-15
Public version status
Update
Distribution status
Not 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
GDYGAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Product Code Classifications

CodeDeviceSpecialtyClass
GDYGauze/Sponge, Internal, X-Ray DetectableGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20686864041584PackageGS120Not in Commercial Distribution
10686864041587PrimaryGS10
00686864041580Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2068686404158420686864041584
1068686404158710686864041587
00686864041580006868640415806868640415800686864041580

GMDN Terms

TermDefinition
Neurosurgical spongeA sterile absorbent material intended to be used on the brain to remove blood and other fluids during an operation. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Cool dry place

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
256880576
Device count
10
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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