FDA.reportPublic FDA data

Screw Rack 3.5mm L65 – L90

Primary DI
07640187461701
Brand
Screw Rack 3.5mm L65 – L90
Company
Bonebridge AG
Model
B-420021
Published
2022-12-23
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
false

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640187461701PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640187461701076401874617017640187461701

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument/implant rackA device designed as a small case, typically with a hinged lid that can be closed to protect the contents (i.e., surgical instruments and/or implantable devices such as plates or screws), and an integral rest(s) with grooves or notches in the upper edge so that the contents can be securely placed, protected, and organized. The lid or rest may be set at an angle to facilitate instrument/implant access during surgical procedures or sterilization. The device is typically be made of stainless steel or a suitable plastic material so that it can be sterilized. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
480244832
Device count
1
DM exempt
false
Premarket exempt
true
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
07640187463392POYA 3.5mm Medial Proximal Tibia Plate, 7 Hole, LeftB-2611002026-05-22
07640187463408POYA 3.5mm Medial Proximal Tibia Plate, 7 Hole, RightB-2621002026-05-22
07640187463415POYA 3.5mm Medial Proximal Tibia Plate, 10 Hole, LeftB-2612002026-05-22
07640187463422POYA 3.5mm Medial Proximal Tibia Plate, 10 Hole, RightB-2622002026-05-22
07640187463439POYA 3.5mm Medial Proximal Tibia Plate, 14 Hole, LeftB-2613002026-05-22
07640187463446POYA 3.5mm Medial Proximal Tibia Plate, 14 Hole, RightB-2623002026-05-22
07640187463460POYA Medial TemplateB-4200452026-05-22
07640187462760TAMINA 3.5mm Proximal Humerus Plate, 7 Hole, Long, LeftB-1214002026-01-16
07640187462777TAMINA 3.5mm Proximal Humerus Plate, 7 Hole, Long, RightB-1224002026-01-16
07640187463125Lag Screw Drill Guide 2.5mmB-4100192026-01-16
07640187463132Drill Bit Ø2.5mm x 140mmB-4200442026-01-16
07640187463149Bending Iron SmallB-4100212026-01-16
07640187463156Bending Plier SmallB-4100222026-01-16
07640187463163Cutting PlierB-4100232026-01-16
07640187463101Monoaxial Drill Guide 2.5mmB-4100172026-01-15
07640187463118Insert Monoaxial Drill Guide 2.5mmB-4100182026-01-15
07640187463187BRUSIO 2.5mm Reinforced Straight Plate, 6 HoleB-1710062026-01-15
07640187463194BRUSIO 2.5mm Reinforced Straight Plate, 10 HoleB-1710102026-01-15
07640187463200BRUSIO 2.5mm Reinforced Straight Plate, 14 HoleB-1710142026-01-15
07640187463217BRUSIO 2.5mm Reinforced Straight Plate, 18 HoleB-1710182026-01-15

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Primary DI, Brand, Company table
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