FDA.report

X-Twist

Primary DI
00816342025409
Brand
X-Twist
Company
PARCUS MEDICAL LLC
Model
XT00001-B
Catalog number
XT00001-B
Device description
X-Twist Mini Sterilization Tray, Base
Published
2022-07-13
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

Related Records

Contact Domains

Product Codes

CodeName
OJHOrthopedic Tray

Product Code Classifications

CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00816342025409PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00816342025409008163420254098163420254090816342025409

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

Contacts

PhoneEmail
9417557965ParcusCS@Anika.com

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
false

Other Devices From This Company

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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