FDA.report

Oil Emulsion Dressing

Primary DI
00714196223807
Brand
Oil Emulsion Dressing
Company
DERMARITE INDUSTRIES LLC
Model
22380
Published
2020-09-01
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
00714196223807PrimaryGS10
01714196223806Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00714196223807007141962238077141962238070714196223807
01714196223806017141962238061714196223806

GMDN Terms

TermDefinition
Wound-nonadherent dressing, permeable, non-antimicrobialA wound covering typically in the form of a porous material (e.g., a fine mesh) impregnated/coated with a substance (e.g., petrolatum, silicone) or made of a material that prevents adherence to the wound bed, thereby decreasing the potential for trauma to the wound and surrounding skin upon removal; it does not contain an antimicrobial agent. Its pores permit the drainage of exudates from, and application of medication to, the wound. It may be used with other wound-care products for chronic and postoperative wounds, burns, skin graft fixation/cultured-cell carrier, cuts, or abrasions; it is neither a dedicated burn dressing nor gauze. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
883925562
Device count
24
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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00714196052636ComfortGauze Border422632025-01-08
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01714196500150SilvaKollagen Gel00500005002023-10-04
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00714196390066AquaRite Extra CMC40220402202021-09-09
00714196390080AquaRite Extra CMC40318403182021-09-09
00714196390103AquaRite Extra CMC404502021-09-09
00714196390127AquaRite Extra CMC406602021-09-09
00714196390141Bordered Foam 4" Round00288E2021-09-09
00714196390165Bordered Foam00297E2021-09-09
00714196390189Bordered Foam00298E2021-09-09
00714196390288Sterile Bordered Gauze112302021-09-09
00714196390301Sterile Bordered Gauze113642021-09-09
00714196390325Sterile Bordered Gauze114102021-09-09

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