FDA.report

PrimaCare®

Primary DI
00809958079324
Brand
PrimaCare®
Company
Derma Sciences Canada Inc
Model
71506LF
Catalog number
DUP71506LF
Device description
6 in X 5 yards premium elastic bandage with removable clips. Sterile
Published
2019-03-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FQMBANDAGE, ELASTIC

Product Code Classifications

CodeDeviceSpecialtyClass
FQMBandage, ElasticGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00809958079324PackageGS124In Commercial Distribution
00809958079317PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00809958079324008099580793248099580793240809958079324
00809958079317008099580793178099580793170809958079317

GMDN Terms

TermDefinition
Dressing-supportive tube/strip, single-useAn elastic device intended to be worn over/around a limb (arm/leg) and/or finger to cover and support a dressing on a wound/injury (e.g., burn, postoperative, skin condition). It may be referred to as a dressing/bandage retainer and is either in the form of a generic tube (i.e., not a specific garment such as a sock, glove, vest, shorts, or hat) or gripping elastic strip made of synthetic material (e.g., nylon/elastane), and is available in various sizes for daily use in the home or healthcare facility. It may additionally be intended for use at other anatomical sites (where size is appropriate) however it is not dedicated to the abdomen/thorax. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags

DUNS number
200564891
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
true
Sterilization required before use
false

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