FDA.report

AMD-RITMED DISTECH ALL GAUZE

Primary DI
20686864053471
Brand
AMD-RITMED DISTECH ALL GAUZE
Company
AMD Medicom Inc
Model
D-3006
Catalog number
D-3006
Device description
AMD-RITMED DISTECH ALL GAUZE SPONGE 12 PLY 4 X 4 Inch
Published
2019-01-14
Public version status
Update
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
NACDressing, wound, hydrophilic

Product Code Classifications

CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20686864053471PackageGS110In Commercial Distribution
10686864053474PrimaryGS10
00686864053477Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2068686405347120686864053471
1068686405347410686864053474
00686864053477006868640534776868640534770686864053477

GMDN Terms

TermDefinition
Woven gauze padA non-medicated device in the form of a patch or swab (also referred to as a sponge) made from woven material (e.g., cotton, cellulose) and primarily designed to absorb fluids for medical purposes; it does not include petrolatum. It is typically used to: clean, cover, or pack wounds or abrasions and absorb their exudates; absorb body-surface exudates; or apply topical medications. 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)636-6262mkansou@medicom.ca

Regulatory Flags

DUNS number
256880576
Device count
200
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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