FDA.report

FLEXIGRIP TUBULAR BNDG SIZE G

Primary DI
00610570069736
Brand
FLEXIGRIP TUBULAR BNDG SIZE G
Company
Bird & Cronin, LLC
Model
08149096
Published
2022-08-20
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

Related Records

Product Codes

CodeName
FQMBandage, Elastic

Product Code Classifications

CodeDeviceSpecialtyClass
FQMBandage, ElasticGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00610570069736PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00610570069736006105700697366105700697360610570069736

GMDN Terms

TermDefinition
Tubular support bandage, non-latex, single-useA tubular elastic non-latex fabric (e.g., polyamide, Lycra) sleeve 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-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
045975349
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
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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