FDA.report

TWISTOFIX

Primary DI
03700586904644
Brand
TWISTOFIX
Company
Stryker Trauma SA
Model
955-4503
Catalog number
955-4503
Device description
Twist-off Screw
Published
2015-09-24
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
true

Related Records

Product Codes

CodeName
HWCScrew, fixation, bone

Product Code Classifications

CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03700586904644PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03700586904644037005869046443700586904644

GMDN Terms

TermDefinition
Gamma-hydroxybutyrate (GHB) IVD, kit, rapid enzyme spectrophotometry, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of gamma-hydroxybutyrate (GHB) in a clinical specimen within a short period relative to standard laboratory testing procedures, using a rapid enzyme spectrophotometry method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Length13Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
481999654
Device count
1
DM exempt
false
Premarket exempt
false
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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