FDA.report

MediChoice

Primary DI
30885632068632
Brand
MediChoice
Company
OWENS & MINOR DISTRIBUTION, INC.
Model
ABD1002
Device description
Abdominal Pad Sterile 7.5 Inch X 8 Inch Single Use Only Not Made With Natural Rubber Latex MediChoice Non-Acute Only
Published
2020-09-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
NABGauze / sponge,nonresorbable for external use

Product Code Classifications

CodeDeviceSpecialtyClass
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20885632068635PackageGS112In Commercial Distribution
30885632068632PackageGS118In Commercial Distribution
10885632068638PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2088563206863520885632068635
3088563206863230885632068632
1088563206863810885632068638

GMDN Terms

TermDefinition
Non-woven gauze pad, sterileA non-medicated sterile 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.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature0 Percent (%) Relative Humidity75 Percent (%) Relative Humidity

Sterilization Methods

Method

Regulatory Flags

DUNS number
007941230
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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