Disposable Tattoo Arm Sleeve Cover Barrier

Primary DI
00616784213736
Brand
Disposable Tattoo Arm Sleeve Cover Barrier
Company
DYNAREX CORPORATION
Model
2137
Device description
Disposable Tattoo Arm Sleeve Cover Barrier, Poly, Blue, Universal
Published
2021-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
FXPCover, Shoe, Operating-Room

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXPCover, Shoe, Operating-RoomGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784213736PackageGS15In Commercial Distribution
00616784213729PrimaryGS10
00616784213712Unit of UseGS10
00810180843171Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784213736006167842137366167842137360616784213736
00616784213729006167842137296167842137290616784213729
00616784213712006167842137126167842137120616784213712
00810180843171008101808431718101808431710810180843171

GMDN Terms#

Term, Definition table
TermDefinition
Limb-worn device coverA device made of fabric or harder materials designed to cover an external prosthetic or orthotic device worn on a limb (e.g., cast, foot orthosis), or an external fixation system for a limb, primarily to function as a hygienic barrier to protect the device and patient from contamination. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
100
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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