FDA.reportPublic FDA data

Nut

Primary DI
09120047297308
Brand
Nut
Company
I.T.S. GmbH
Model
62700-3
Catalog number
62700-3
Device description
Nut
Published
2018-11-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
09120047297308PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09120047297308091200472973089120047297308

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone nutA sterile profiled block made of metallic or non-metallic material that is threaded on its inside surface, and designed to securely fasten a bone fixation bolt, possibly with a washer. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
303456917
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
09120047301241Cannulated Tibia Nail11210-36011210-3602016-09-14
09120047301364Cannulated Tibia Nail11209-28511209-2852016-09-14
09120047301371Cannulated Tibia Nail11209-30011209-3002016-09-14
09120047301388Cannulated Tibia Nail11209-40511209-4052016-09-14
09120047301395Cannulated Tibia Nail11210-28511210-2852016-09-14
09120047301418Cannulated Tibia Nail11209-33011209-3302016-09-14
09120047301425Cannulated Tibia Nail11209-34511209-3452016-09-14
09120047301432Cannulated Tibia Nail11209-36011209-3602016-09-14
09120047301449Cannulated Tibia Nail11209-37511209-3752016-09-14
09120047301456Cannulated Tibia Nail11209-39011209-3902016-09-14
09120047301692Cannulated Tibia Nail11210-31511210-3152016-09-14
09120047301722Cannulated Tibia Nail11210-33011210-3302016-09-14
09120047301739Cannulated Tibia Nail11210-34511210-3452016-09-14
09120047301968Cannulated Tibia Nail11209-31511209-3152016-09-14
09120047302118Cannulated Tibia Nail11210-39011210-3902016-09-14
09120047302156Cannulated Femur Nail, Right12110-30012110-3002016-09-14
09120047302163Cannulated Femur Nail, Left12210-30012210-3002016-09-14
09120047302194Cannulated Femur Nail, Right12112-30012112-3002016-09-14
09120047302200Cannulated Femur Nail, Left12212-30012212-3002016-09-14
09120047303214Cannulated Femur Nail, Right12112-42012112-4202016-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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