FDA.report

Tubigrip®

Primary DI
07332551947934
Brand
Tubigrip®
Company
Mölnlycke Health Care AB
Model
1437
Device description
Tubigrip D Natural x 10m
Published
2022-10-21
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
false

Related Records

Contact Domains

Product Codes

CodeName
FQMBANDAGE, ELASTIC

Product Code Classifications

CodeDeviceSpecialtyClass
FQMBandage, ElasticGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07332551449469PackageGS11In Commercial Distribution
07332551947934PackageGS128In Commercial Distribution
07332551449476PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07332551449469073325514494697332551449469
07332551947934073325519479347332551947934
07332551449476073325514494767332551449476

GMDN Terms

TermDefinition
Tubular support bandage, Hevea-latexA tubular, elastic fabric sleeve which includes Hevea natural rubber latex (NRL) intended to be externally worn on a limb to provide support or local pressure to a part of the body, especially a joint, for various preventative/therapeutic applications (e.g., support soft tissue injuries) while enabling movement. Sometimes referred to as a tubigrip, it may be designed to accommodate one or more anatomies (e.g., ankles, knees, wrists). It is not designed specifically to apply an even or graduated force to the limb (i.e., not a compression/pressure garment). This is a single-patient, reusable device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
+46737733775pedro.lopes@molnlycke.com

Regulatory Flags

DUNS number
631770658
Device count
1
DM exempt
true
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
true
No natural rubber latex
false
Sterilization required before use
false

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