FDA.report

Rite Aid

Primary DI
10011822089477
Brand
Rite Aid
Company
Aso LLC
Model
011822089470
Device description
Hydrogel Burn Pads, all one size, 1.96 IN x 2.95 IN (49 mm x 74 mm)
Published
2021-01-19
Public version status
New
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
NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic

Product Code Classifications

CodeDeviceSpecialtyClass
NAEDressing, Wound, Hydrogel Without Drug And/Or BiologicGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10011822089477PackageGS172In Commercial Distribution
00011822089470PrimaryGS10
60011822089472Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1001182208947710011822089477
00011822089470000118220894700118220894700011822089470
6001182208947260011822089472

GMDN Terms

TermDefinition
Wound hydrogel dressing, non-antimicrobialA wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases; it does not include an antimicrobial agent(s). This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
18558234545xx@xx.xx

Regulatory Flags

DUNS number
152793493
Device count
4
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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