FDA.report

Vault C ACDF System

Primary DI
00840019916660
Brand
Vault C ACDF System
Company
PRECISION SPINE, INC.
Model
37-RS-0412
Catalog number
37-RS-0412
Device description
Rasp, 0° Lordosis, 14x12 - 11/12mm
Published
2019-03-28
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
HTRRasp

Product Code Classifications

CodeDeviceSpecialtyClass
HTRRaspGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840019916660PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840019916660008400199166608400199166600840019916660

GMDN Terms

TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
079398589
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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

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00840019971263Reform Ti Modular39-SF-853539-SF-85352026-01-13
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00840019971287Reform Ti Modular39-SF-854539-SF-85452026-01-13
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00840019971317Reform Ti Modular39-SF-856039-SF-85602026-01-13
00840019971324Reform Ti Modular39-SF-857039-SF-85702026-01-13

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