FDA.report

PRECICE Screw Tray

Primary DI
00887517001092
Brand
PRECICE Screw Tray
Company
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
Model
STU1-001
Catalog number
STU1-001
Device description
Screw tray containing locking screws
Published
2017-10-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HSBRod, Fixation, Intramedullary And Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00887517001092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00887517001092008875170010928875170010920887517001092

GMDN Terms

TermDefinition
Instrument trayA container intended to provide a suitable platform for containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during reprocessing/sterilization procedures, however it is not dedicated to reprocessing/sterilization. It is typically designed as a shallow vessel with a raised rim, or as a deeper cassette-like device, and it might include a lid. It is designed to fit into other devices such as supply trolleys, storage systems and sterilizers. This is a reusable device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
855-435-5477csdepartment@nuvasive.com
866-456-2871info@globusmedical.com

Regulatory Flags

DUNS number
837845234
Device count
1
DM exempt
false
Premarket exempt
false
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 DIBrandModelCatalogPublished
00195377024282Precice InstrumentOSR2-0002023-01-26
00195377066206Precice InstrumentSPAS-3.22023-01-26
00195377066305Precice Ankle Salvage SystemAST1-0002023-01-26
00195377066701Precice InstrumentSPT1-0002023-01-26
00195377066718Precice InstrumentSPR1-0002023-01-26
00812258028602Precice InstrumentSDG2-0002023-01-26
00887517001238Precice InstrumentOSG1-0002023-01-26
00887517001252Precice InstrumentOSG3-0002023-01-26
00887517001290Precice InstrumentCRT1-0002023-01-26
00887517001313Precice InstrumentOSP5-0752023-01-26
00887517001320Precice InstrumentOSP5-1002023-01-26
00887517054272Precice InstrumentsOTA1-0002023-01-26
00887517885234Precice InstrumentHCB3-0002023-01-26
00887517937148Precice InstrumentKWS1-0022023-01-26
00887517937155Precice InstrumentKWS2-0002023-01-26
00195377168276PRECICE ScrewsTSA5-100TSA5-1002017-10-09
00195377168283PRECICE ScrewsTSA5-095TSA5-0952017-10-09
00195377168290PRECICE ScrewsTSA5-080TSA5-0802017-10-09
00195377168603PRECICE ScrewsTSA5-070TSA5-0702017-10-09
00195377168610PRECICE ScrewsTSA5-060TSA5-0602017-10-09

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00889024700291Affixus®Zimmer, Inc.HSB2026-03-19
00888867463363Arthrex®ARTHREX, INC.HSB2026-03-16
00888867529069Arthrex®ARTHREX, INC.HSB2026-03-16
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