FDA.report

Monster Screw System

Primary DI
00889795035325
Brand
Monster Screw System
Company
PARAGON 28, INC.
Model
P20-070-WB00
Catalog number
P20-070-WB00
Device description
Monster Screw Bowl Washer, 7.0mm
Published
2019-10-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
00889795035325PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00889795035325008897950353258897950353250889795035325

GMDN Terms

TermDefinition
Orthopaedic bone washer, non-sterileA non-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
042961576
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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