FDA.report

N/A

Primary DI
00614138114241
Brand
N/A
Company
TETRA MEDICAL SUPPLY CORP.
Model
280600
Catalog number
280600
Device description
SYNTHETIC CAST PADDING 6IN X 4YD
Published
2022-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
ITGBandage, Cast

Product Code Classifications

CodeDeviceSpecialtyClass
ITGBandage, CastPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00614138114241PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00614138114241006141381142416141381142410614138114241

GMDN Terms

TermDefinition
General-purpose medical fibre paddingA roll, sheet or preformed shape of synthetic (e.g., polyester, polypropylene) or natural (e.g., cotton) fibre intended to be applied to and/or compress a local area of the body for various preventative/therapeutic applications (e.g., in compression bandaging, padding under casts and splints, padding for anatomical depressions), typically over intact and healthy skin. It is intended for use in the home or a clinical setting. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
18006214041sales@tetramed.com

Regulatory Flags

DUNS number
047580212
Device count
1
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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