FDA.reportPublic FDA data

Tiger

Primary DI
00812926025179
Brand
Tiger
Company
Trilliant Surgical, LLC
Model
215-55-009
Device description
5.5mm Screw Trocar
Published
2018-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812926025179PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812926025179008129260251798129260251790812926025179

GMDN Terms#

Term, Definition table
TermDefinition
Intraoperative bone pin/screw, non-sterileA small non-sterile rod intended to be inserted into bone to temporarily anchor a surgical instrument (e.g., retractor, implant aligner) to bone during an orthopaedic surgical procedure; it is not left in situ after the procedure. It may be wholly- or partially-threaded for screwing into bone, and may have other physical features to enable fixation of surgical instruments. It is made of metallic (e.g., stainless steel) or polymer (radiolucent) material and is available in various shapes and sizes. 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
828829072
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190446898801Arsenal Foot330-60-0062026-03-19
00810028397385Tiger201-30-0422024-06-04
00810028399099Tiger201-40-2102024-06-04
00810028399464Tiger203-20-0162024-06-04
00850062461949Tibial Impactor Tips 920-0061-042024-08-09
00810028391840Arsenal Ankle340-00-0032022-05-02
00812926028804Hook Tamp320-00-0202019-03-11
008129260201293S Hemi111-00-0022018-09-23
008129260202283S Hemi111-00-0122018-09-23
00812926027043Two-Step Hammertoe214-00-0142018-09-23
008129260280333S Hemi111-00-0132018-09-23
00812926028187Staple Tamp510-00-0052018-09-23
00810028398344Tiger201-20-0082024-05-31
00810028395343Arsenal Foot300-82-0252024-03-27
00810028395206Arsenal Foot300-82-0112024-03-21
00810028395213Arsenal Foot300-82-0122024-03-21
00810028395220Arsenal Foot300-82-0132024-03-21
00810028395237Arsenal Foot300-82-0142024-03-21
00810028395244Arsenal Foot300-82-0152024-03-21
00810028395251Arsenal Foot300-82-0162024-03-21

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