FDA.report

NA

Primary DI
23596010095323
Brand
NA
Company
Smith & Nephew, Inc.
Model
014407
Catalog number
014407
Device description
FOOT STRAP ANKLE DSTRCTR STRL(6)
Published
2015-08-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KQZCOMPONENT, TRACTION, NON-INVASIVE

Product Code Classifications

CodeDeviceSpecialtyClass
KQZComponent, Traction, Non-InvasiveOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
23596010095323PackageGS16In Commercial Distribution
03596010095329PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
2359601009532323596010095323
03596010095329035960100953293596010095329

GMDN Terms

TermDefinition
Limb/torso/head restraint, single-useA non-rigid device, typically a strap(s) or band(s), intended to be temporarily placed on or around one or more parts of a patient’s body (e.g., torso, limbs, head) to restrict movement, to facilitate patient positioning and stabilization during a medical procedure, and/or to prevent injury/hazards. It is made of various materials (e.g., fabric, nylon, leather, or foam) and typically anchored to a fixture or furniture part (e.g., a bedrail, operating table). It is not intended for immobilization of specific joint. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)821-5700gudid@smith-nephew.com
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags

DUNS number
109903521
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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