FDA.report

MediChoice

Primary DI
20885632070102
Brand
MediChoice
Company
OWENS & MINOR DISTRIBUTION, INC.
Model
NADSG101
Device description
Non-Adherent Dressing Sterile 2 Inch X 3 Inch Single Use Only Not Made With Natural Rubber Latex MediChoice Non-Acute Only
Published
2020-09-21
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
NADDressing, wound, occlusive

Product Code Classifications

CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20885632070102PackageGS124In Commercial Distribution
30885632070109PackageGS1100In Commercial Distribution
10885632070105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2088563207010220885632070102
3088563207010930885632070109
1088563207010510885632070105

GMDN Terms

TermDefinition
Wound-nonadherent dressing, absorbent, non-antimicrobialA wound covering typically in the form of a multi-layered pad having a material or substance on its skin-contact surface (e.g., silicone gel), or designed to be soaked in saline prior to application, to prevent adherence to the wound bed thereby decreasing wound trauma potential; it does not contain an antimicrobial agent. It is typically used to absorb wound blood/exudates while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites; it is not a dedicated burn dressing. This is a single-use device.

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

Other Devices From This Company

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10885632516429SurgiTrackSM4500309F242026-03-17
30885632495469HalyardIDSG10012026-03-13
20885632495851HalyardIDSG10022026-03-13
20885632495868HalyardIDSG10032026-03-13
20885632495875HalyardIDSG10042026-03-13
20885632495882HalyardIDSG10052026-03-13
20885632496742HalyardIDSG10062026-03-13

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20885632495868HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-03-13
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20885632495882HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-03-13
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20885632496766HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-03-13
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