FDA.report

OTHER EXTERNAL FIXATION

Primary DI
03596010033543
Brand
OTHER EXTERNAL FIXATION
Company
Smith & Nephew, Inc.
Model
110060
Catalog number
110060
Device description
STEINMANN PIN TRACTOR LOOP LARGE
Published
2015-08-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HSTAPPARATUS, TRACTION, NON-POWERED

Product Code Classifications

CodeDeviceSpecialtyClass
HSTApparatus, Traction, Non-PoweredOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03596010033543PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03596010033543035960100335433596010033543

GMDN Terms

TermDefinition
Traction system spreader barA metal bar that has curved-hoop segments for attaching hooks or pins to perform traction with an external traction system. The bar is adjustable and is used to vary the angle at which the system's cord applies traction, via harnesses attached to the head or pelvic area, to affect the cervical or lumbar vertebrae.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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