FDA.report

Washer, OD=16/25mm, ID=9mm

Primary DI
09120069818086
Brand
Washer, OD=16/25mm, ID=9mm
Company
I.T.S. GmbH
Model
36851
Published
2022-10-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
HTNWasher, Bolt Nut

Product Code Classifications

CodeDeviceSpecialtyClass
HTNWasher, Bolt NutOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
09120069818086PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
09120069818086091200698180869120069818086

GMDN Terms

TermDefinition
Orthopaedic bone washer, sterileA sterile flat thin ring or plate designed to be used with a nut and bolt/screw to improve tightness in an orthopaedic 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
303456917
Device count
1
DM exempt
true
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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