FDA.report

Synth-X SL

Primary DI
03760177046313
Brand
Synth-X SL
Company
TEKNIMED
Model
HC-SX-SL
Catalog number
HC-SX-SL
Published
2020-09-24
Public version status
New
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

Product Codes

CodeName
NDNCement, Bone, Vertebroplasty

Product Code Classifications

CodeDeviceSpecialtyClass
NDNCement, Bone, VertebroplastyOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03760177046313PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03760177046313037601770463133760177046313

GMDN Terms

TermDefinition
Vertebral bone filler, non-bioabsorbableA sterile substance intended to be used to replace cortical/cancellous bone in a vertebral body to stabilize vertebral compression fractures (VCFs) caused by cancer, osteoporosis, or trauma. The device may be a sterile powder of a synthetic polymer [e.g., polymethylmethacrylate (PMMA)] that is mixed with its sterile diluent, or a non-PMMA-containing elastomer formed by mixing two precursors, prior to implantation typically during a balloon kyphoplasty or vertebroplasty procedure. This device does not contain an antibiotic agent. After application, this device cannot be reused.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
764746723
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
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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03760177040113OPACITY +T040320ZT040320Z2015-10-16
03760177041110F20T040520T0405202015-10-16
03760177041721HIGH V+T040321T0403212017-08-22
03760177042391EXOFIXT040323T0403232015-10-16

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03701505801235DynamoTEKNIMEDNDN2026-02-02
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