FDA.reportPublic FDA data

Monster Screw System

Primary DI
00889795001238
Brand
Monster Screw System
Company
PARAGON 28, INC.
Model
P20-070-WF00
Catalog number
P20-070-WF00
Device description
Flat Washer for Monster Screw 7.0mm
Published
2016-09-24
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

Product Codes#

Code, Name table
CodeName
HTNWASHER, BOLT NUT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTNWasher, Bolt NutOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889795001238PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889795001238008897950012388897950012380889795001238

GMDN Terms#

Term, Definition table
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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Outer Diameter2Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
042961576
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889795153845Baby Gorilla/Gorilla Plating SystemP50-900-BGSL-1P50-900-BGSL-12026-02-19
00889795153852Baby Gorilla/Gorilla Plating SystemP50-900-BGSL-2P50-900-BGSL-22026-02-19
00889795153883Baby Gorilla/Gorilla Plating SystemP50-900-BGSL-3P50-900-BGSL-32026-02-19
00889795153890Baby Gorilla/Gorilla Plating SystemP50-900-BGSL-4P50-900-BGSL-42026-02-19
00889795153906Baby Gorilla/Gorilla Plating SystemP50-900-SBSL-1P50-900-SBSL-12026-02-19
00889795153913Baby Gorilla/Gorilla Plating SystemP50-900-SBSL-2P50-900-SBSL-22026-02-19
00889795153944Baby Gorilla/Gorilla Plating SystemP50-900-SBSL-3P50-900-SBSL-32026-02-19
00889795153951Baby Gorilla/Gorilla Plating SystemP50-900-SBSL-4P50-900-SBSL-42026-02-19
00889795153968Baby Gorilla/Gorilla Plating SystemP50-900-SBSL-5P50-900-SBSL-52026-02-19
00889795153975Baby Gorilla/Gorilla Plating SystemP50-900-SBSL-6P50-900-SBSL-62026-02-19
00889795153982Baby Gorilla/Gorilla Plating SystemP50-900-SBSL-7P50-900-SBSL-72026-02-19
00889795153999Baby Gorilla/Gorilla Plating SystemP50-900-BGSL-5P50-900-BGSL-52026-02-19
00889795154002Baby Gorilla/Gorilla Plating SystemP50-900-BGSL-6P50-900-BGSL-62026-02-19
00889795154019Baby Gorilla/Gorilla Plating SystemP50-900-BGSL-7P50-900-BGSL-72026-02-19
00889795154026APEX 3D Total Ankle Replacement SystemP10-844-FTPPP10-844-FTPP2026-02-19
00889795153661Precision MIS Bunion SystemP27-200-1000P27-200-10002026-02-06
00889795128737Baby Gorilla/Gorilla Plating SystemP99-151-P51L-SP99-151-P51L-S2026-01-29
00889795110879APEX 3D Total Ankle Replacement SystemP99-151-P105-1-SP99-151-P105-1-S2026-01-28
00889795118400APEX 3D Total Ankle Replacement SystemP99-152-P104-SP99-152-P104-S2026-01-28
00889795118417APEX 3D Total Ankle Replacement SystemP99-152-P105-SP99-152-P105-S2026-01-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888867529045Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529052Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529106Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529120Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529168Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529199Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529205Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529229Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529236Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529243Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529281Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529328Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529335Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529410Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529427Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529472Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529519Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529540Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529557Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529588Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529601Arthrex®ARTHREX, INC.HTN2026-03-16
00888867530072Arthrex®ARTHREX, INC.HTN2026-03-16
00888867530096Arthrex®ARTHREX, INC.HTN2026-03-16
00888867530195Arthrex®ARTHREX, INC.HTN2026-03-16
00888867531895Arthrex®ARTHREX, INC.HTN2026-03-16
00888867531949Arthrex®ARTHREX, INC.HTN2026-03-16
00888867531970Arthrex®ARTHREX, INC.HTN2026-03-16
00888867531987Arthrex®ARTHREX, INC.HTN2026-03-16
00888867532014Arthrex®ARTHREX, INC.HTN2026-03-16
00888867532038Arthrex®ARTHREX, INC.HTN2026-03-16