FDA.reportPublic FDA data

Parcus Instrumentation

Primary DI
00816342020480
Brand
Parcus Instrumentation
Company
PARCUS MEDICAL LLC
Model
10057
Device description
GFS Depth Gauge
Published
2022-12-06
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
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
00816342020480PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816342020480008163420204808163420204800816342020480

GMDN Terms#

Term, Definition table
TermDefinition
Surgical depth gauge, reusableA surgical instrument designed to measure the depth of a recess, usually to measure the depth of holes being drilled in bone so that the surgeon can determine the length of the bone screw to be used. It may take two forms: 1) a device with a moveable (sliding) centrepiece (a prong), the tip of which is inserted into the recess to read from a scale; 2) a circular disc with a central hole which is clipped to a drill bit so that the device slides up as the drill bit is advanced. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
859961950
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
true
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
00816342022491X-Twist BiocompositeXT447002025-04-29
00816342025447X-Twist BiocompositeXT447012025-04-29
00816342025454X-Twist BiocompositeXT447022025-04-29
00816342025461X-Twist BiocompositeXT447032025-04-29
00816342025478X-Twist BiocompositeXT455002025-04-29
00816342025485X-Twist BiocompositeXT455012025-04-29
00816342025492X-Twist BiocompositeXT455022025-04-29
00816342025508X-Twist BiocompositeXT455032025-04-29
00816342025515X-Twist BiocompositeXT462002025-04-29
00816342025539ProPass202552025-04-29
00816342025546ProPass202562025-04-29
00816342025553ProPass116792025-04-29
00816342023573Parcus Instrumentation11019U2023-07-29
00816342023580Parcus Instrumentation10873U2023-07-29
00816342023634Parcus Instrumentation10482U2023-07-29
00816342023658Parcus Instrumentation10874U2023-07-29
00816342023726Parcus Instrumentation200982023-07-29
00816342023740Parcus Instrumentation10615HU2023-07-29
00816342023795Knotless Push-In Suture Anchor109942023-07-29
00816342023931Twist PEEK Suture Anchor110032023-07-29

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Primary DI, Brand, Company table
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