FDA.report

Cotton Roll

Primary DI
00616784325033
Brand
Cotton Roll
Company
DYNAREX CORPORATION
Model
3250
Device description
Cotton Rolls #2 Medium
Published
2021-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
EFNCotton, Roll

Product Code Classifications

CodeDeviceSpecialtyClass
EFNCotton, RollDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784325033PackageGS110In Commercial Distribution
00616784325026PrimaryGS10
00616784325019Unit of UseGS10
00810180844185Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784325033006167843250336167843250330616784325033
00616784325026006167843250266167843250260616784325026
00616784325019006167843250196167843250190616784325019
00810180844185008101808441858101808441850810180844185

GMDN Terms

TermDefinition
Cotton wool roll, non-sterileA device designed as an absorbent, non-sterile mass of cotton or man-made fibres formed in a continuous length (roll) and typically used as a general-purpose absorbent or padding within the healthcare sector or the home; it is not in the form of a bandage or dedicated dressing. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
Device count
2000
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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