FDA.reportPublic FDA data

4.5mm Drill Sleeve Assembly

Primary DI
00812926029481
Brand
4.5mm Drill Sleeve Assembly
Company
TRILLIANT SURGICAL, LTD.
Model
210-45-006
Published
2019-03-13
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
false

Product Codes#

Code, Name table
CodeName
FZXGuide, Surgical, Instrument

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812926029481PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812926029481008129260294818129260294810812926029481

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implantation sleeve, reusableA hand-held tubular surgical device designed to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw), facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smaller diameter sleeve) through it, stabilize an instrument/implant coupling, and/or protect the surgeon's gloved hand or patient tissue. It is not primarily intended to place, angle, and guide a rotating surgical drill. It is typically made of high-grade stainless steel and/or synthetic materials and is available in various sizes and lengths. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
828829072
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
008129260294434.5mm Cannulated Over Drill Bit210-45-0112019-03-13
008129260290544.5mm x 20mm FTTCS200-45-2202019-03-11
008129260290614.5mm x 22mm FTTCS200-45-2222019-03-11
008129260290784.5mm x 24mm FTTCS200-45-2242019-03-11
008129260290854.5mm x 26mm FTTCS200-45-2262019-03-11
008129260290924.5mm x 28mm FTTCS200-45-2282019-03-11
008129260291084.5mm x 30mm FTTCS200-45-2302019-03-11
008129260291154.5mm x 32mm FTTCS200-45-2322019-03-11
008129260291224.5mm x 34mm FTTCS200-45-2342019-03-11
008129260291394.5mm x 36mm FTTCS200-45-2362019-03-11
008129260291464.5mm x 38mm FTTCS200-45-2382019-03-11
008129260291534.5mm x 40mm FTTCS200-45-2402019-03-11
008129260291604.5mm x 45mm FTTCS200-45-2452019-03-11
008129260291774.5mm x 50mm FTTCS200-45-2502019-03-11
008129260291844.5mm x 55mm FTTCS200-45-2552019-03-11
008129260291914.5mm x 60mm FTTCS200-45-2602019-03-11
008129260292074.5mm x 65mm FTTCS200-45-2652019-03-11
008129260292144.5mm x 70mm FTTCS200-45-2702019-03-11

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G079INL1160070Inlet Bone Fixation SystemIntelivation, LLCFZX2026-04-17
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07640375235732PERLA ® TL MISSpineArt SAFZX2025-11-10
G79153202001620G0WishFIXRed Star Contract Manufacturing Inc.FZX2025-10-06
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08800071084419Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
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08800071084433Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
G463090799PK0Spine InstrumentsBOXSPINE HOLDINGS, INC.FZX2025-01-16
008101182101673.7mm Parallel PinOsteocentric Technologies, Inc.FZX2023-10-30
008101182101744.2mm Parallel PinOsteocentric Technologies, Inc.FZX2023-10-30
008101182101815.5mm Parallel PinOsteocentric Technologies, Inc.FZX2023-10-30
08800089436033Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17