FDA.report

AMD-RITMED

Primary DI
20686864042895
Brand
AMD-RITMED
Company
AMD Medicom Inc
Model
53243
Catalog number
53243
Device description
AMD-RITMED CYLINDRICAL SPONGES STRUNG X-RAY DETECTABLE 3/8 X 1 1/2 Inch
Published
2019-01-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
20686864042895PrimaryGS10
00686864042891Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2068686404289520686864042895
00686864042891006868640428916868640428910686864042891

GMDN Terms

TermDefinition
Cotton wool roll, non-sterileA device designed as an absorbent, non-sterile mass of cotton or man-made fibres formed in a continuous length (roll) and typically used as a general-purpose absorbent or padding within the healthcare sector or the home; it is not in the form of a bandage or dedicated dressing. It is normally available [non-prescription] over-the-counter (OTC). 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)636-6262dabecassis@amdritmed.com

Regulatory Flags

DUNS number
256880576
Device count
500
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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