PolyLock

Primary DI
00840124506282
Brand
PolyLock
Company
FUSION ORTHOPEDICS, LLC
Model
CD-SB-1921
Catalog number
CD-SB-1921
Device description
Bunion Plate Distall Drill 2.7mm SB
Published
2021-11-22
Public version status
New
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
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840124506282PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840124506282008401245062828401245062820840124506282

GMDN Terms#

Term, Definition table
TermDefinition
Cannulated surgical drill bit, single-use, non-sterileA non-sterile metal shaft intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) in order to clear a channel of the same diameter as the shaft, typically for the insertion of a prosthetic device or other orthopaedic implant. It has a hollow centre so it can be fed over a drill guiding pin, and may be flexible; devices to assist the procedure (e.g., drill guiding pin, manual driver) may be included. This is a single-use device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
080307067
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
true
Expiration date on label
true
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
00840124525474PolyLock MidfootMF-LK-2748MF-LK-27482026-03-10
00840124525481PolyLock MidfootMF-NL-2748MF-NL-27482026-03-10
00840124525450Depth GaugeTN-DG-8000TN-DG-80002026-03-06
00840124525375FuzeFix Max FTFX-FT-2532-SFX-FT-2532-S2026-02-17
00840124525382FuzeFix Max FTFX-FT-2534-SFX-FT-2534-S2026-02-17
00840124525399FuzeFix Max FTFX-FT-2536-SFX-FT-2536-S2026-02-17
00840124525405FuzeFix Max FTFX-FT-2538-SFX-FT-2538-S2026-02-17
00840124525412FuzeFix Max FTFX-FT-2542-SFX-FT-2542-S2026-02-17
00840124525429FuzeFix Max FTFX-FT-2544-SFX-FT-2544-S2026-02-17
00840124525436FuzeFix Max FTFX-FT-2546-SFX-FT-2546-S2026-02-17
00840124525443FuzeFix Max FTFX-FT-2548-SFX-FT-2548-S2026-02-17
00840124525320FuzeFix MiniTN-FX-6012TN-FX-60122026-02-03
00840124525337FuzeFix MiniTN-FX-6013TN-FX-60132026-02-03
00840124525344Metalogix RevolutionTN-TR-0095TN-TR-00952026-02-03
00840124525351Metalogix RevolutionTN-TR-0094TN-TR-00942026-02-03
00840124525368Metalogix RevolutionTN-TR-0090TN-TR-00902026-02-03
00840124525245FuzeFix MiniTN-FX-6011TN-FX-60112026-01-22
00840124525252Metalogix RevolutionTN-TR-0091TN-TR-00912026-01-22
00840124525269Metalogix RevolutionMX-RP-0120MX-RP-01202026-01-22
00840124525276Metalogix RevolutionMX-RP-0140MX-RP-01402026-01-22

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