FDA.report

AMD-RITMED

Primary DI
12686864050587
Brand
AMD-RITMED
Company
AMD Medicom Inc
Model
A2240
Catalog number
A2240
Device description
AMD-RITMED NON-WOVEN SPONGES 4 PLY 2 x 2 Inch
Published
2019-01-15
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
NACDressing, wound, hydrophilic

Product Code Classifications

CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
12686864050587PackageGS150In Commercial Distribution
20686864050586PackageGS130In Commercial Distribution
30686864050583PackageGS150In Commercial Distribution
10686864050589PrimaryGS10
00686864050582Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1268686405058712686864050587
2068686405058620686864050586
3068686405058330686864050583
1068686405058910686864050589
00686864050582006868640505826868640505820686864050582

GMDN Terms

TermDefinition
Non-woven gauze padA non-medicated device in the form of a patch or swab (also referred to as a sponge) made from non-woven material (e.g., rayon/polyester) and primarily designed to absorb fluids for medical purposes. It is typically used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates, or to apply topical medications; it is intended to produce less lint and be less adherent than basic woven gauze pads; it does not include petrolatum. 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
+1(514)636-6262abelacel@medicom.ca

Regulatory Flags

DUNS number
256880576
Device count
2
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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