FDA.report

Cuticell®

Primary DI
04042809271508
Brand
Cuticell®
Company
BSN medical GmbH
Model
72539-04
Catalog number
72539-04
Device description
CUTICELL STERILE 20CMX40CM 1 25/BOX
Published
2022-12-08
Public version status
Update
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
NADDressing, wound, occlusive

Product Code Classifications

CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04042809271492PackageGS125In Commercial Distribution
04042809271508PackageGS16In Commercial Distribution
04042809271485PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04042809271492040428092714924042809271492
04042809271508040428092715084042809271508
04042809271485040428092714854042809271485

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.

Device Sizes

TypeValueUnit
Length40Centimeter
Width20Centimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)537-1063HMS.ORDERS@ESSITY.COM

Regulatory Flags

DUNS number
342651662
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
true
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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