FDA.report

Parcus Instrumentation

Primary DI
00816342020497
Brand
Parcus Instrumentation
Company
PARCUS MEDICAL LLC
Model
10077
Device description
ACL TRAY SYSTEM
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

Related Records

Product Codes

CodeName
OJHOrthopedic Tray

Product Code Classifications

CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00816342020497PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00816342020497008163420204978163420204970816342020497

GMDN Terms

TermDefinition
Surgical instrument/implant rackA device designed as a small case, typically with a hinged lid that can be closed to protect the contents (i.e., surgical instruments and/or implantable devices such as plates or screws), and an integral rest(s) with grooves or notches in the upper edge so that the contents can be securely placed, protected, and organized. The lid or rest may be set at an angle to facilitate instrument/implant access during surgical procedures or sterilization. The device is typically be made of stainless steel or a suitable plastic material so that it can be sterilized. This is a reusable device.

Sterilization Methods

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

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00816342025515X-Twist BiocompositeXT462002025-04-29
00816342025539ProPass202552025-04-29
00816342025546ProPass202562025-04-29
00816342025553ProPass116792025-04-29
00816342023573Parcus Instrumentation11019U2023-07-29
00816342023580Parcus Instrumentation10873U2023-07-29
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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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00191072241993ACSAMERICAN CONTRACT SYSTEMS, INC.OJH2026-03-24
00191072242006ACSAMERICAN CONTRACT SYSTEMS, INC.OJH2026-03-24
00191072242013ACSAMERICAN CONTRACT SYSTEMS, INC.OJH2026-03-24
00191072242020ACSAMERICAN CONTRACT SYSTEMS, INC.OJH2026-03-24
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