FDA.reportPublic FDA data

Calibrated Spreader

Primary DI
00812926029528
Brand
Calibrated Spreader
Company
TRILLIANT SURGICAL, LTD.
Model
330-00-001
Published
2019-10-01
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
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812926029528PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812926029528008129260295288129260295280812926029528

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, reusableA hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. 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
00810028391512Arsenal Petite MPJ Plate, L, 0°300-82-0072021-09-03
00810028391529Arsenal Petite MPJ Plate, R, 0°300-82-0082021-09-03
00810028391536Arsenal Petite MPJ Plate, L, 5°300-82-0092021-09-03
00810028391543Arsenal Petite MPJ Plate, R, 5°300-82-0102021-09-03
00810028391550Arsenal Short 5th Met Hook Plate, L300-84-0032021-09-03
00810028391567Arsenal Short 5th Met Hook Plate, R300-84-0042021-09-03
00810028391574Arsenal U-Plate, Small, L300-85-0052021-09-03
00810028391581Arsenal U-Plate, Small, R300-85-0062021-09-03
00810028391598Arsenal U-Plate, Standard, L300-85-0072021-09-03
00810028391604Arsenal U-Plate, Standard, R300-85-0082021-09-03
00810028391420Arsenal Modular Tray Lid330-01-2012021-06-28
00810028391437Arsenal Modular Tray Sublevel330-01-2022021-06-28
00810028391444Arsenal 2.7mm/3.5mm Screw Module330-01-2032021-06-28
00810028391451Arsenal Modular Caddy Base330-01-2042021-06-28
00810028391468Arsenal Modular Caddy Lid330-01-2052021-06-28
00810028391475Arsenal MPJ Plating Caddy330-01-2062021-06-28
00810028391482Arsenal Reamer Caddy330-01-2072021-06-28
00810028391499Arsenal Lapidus Plating Caddy330-01-2082021-06-28
00810028391505Arsenal Universal Plating Caddy330-01-2092021-06-28
00812926029917K-Wire Tube330-01-2102021-06-28

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Primary DI, Brand, Company table
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