FDA.reportPublic FDA data

TWISTOFIX

Primary DI
03700586904613
Brand
TWISTOFIX
Company
Stryker GmbH
Model
955-4500
Catalog number
955-4500
Device description
Twist-off Screw
Published
2015-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
HWCScrew, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700586904613PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700586904613037005869046133700586904613

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length10Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
481999654
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327625066PANGEA5421165421162024-12-01
00886385019741SR PIP17-13152017-06-27
00886385019758SR PIP17-13162017-06-27
00886385019765SR PIP17-13172017-06-27
00886385019772SR PIP17-13182017-06-27
00886385019789SR PIP17-13192017-06-27
00886385019796SR PIP17-13202017-06-27
00886385019802SR PIP17-13212017-06-27
00886385019819SR PIP17-13222017-06-27
00886385019826SR PIP17-13232017-06-27
00886385019833SR PIP17-13242017-06-27
00886385019840SR PIP17-13252017-06-27
00886385019857SR PIP17-13262017-06-27
00886385019864SR PIP17-13272017-06-27
00886385019871SR PIP17-13282017-06-27
00886385019888SR PIP17-13292017-06-27
00886385019895SR PIP17-13302017-06-27
00886385019901SR PIP17-13312017-06-27
00886385019918SR PIP17-13322017-06-27
00886385019925SR PIP17-13332017-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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