FDA.report

CARDINAL HEALTH

Primary DI
10885380089060
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
WS100
Catalog number
WS100
Device description
Washer 10.0mm Material: 316L Stainless Steel
Published
2018-06-28
Public version status
Update
Distribution status
Not 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
10885380089060PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088538008906010885380089060

GMDN Terms

TermDefinition
Implantable bone washerAn implantable, flat ring or plate designed to be used with a nut and bolt/screw to improve tightness in an orthopaedic, spinal, and/or craniofacial bone fixation assembly. It may be made of metal, polymer, or reinforced polymer. This is a single-use device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
961027315
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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