FDA.report

NA

Primary DI
00840200405539
Brand
NA
Company
Integrity Implants Inc.
Model
CMP-02154
Catalog number
CMP-02154
Device description
1.4mm Kirschner Wire XL, NiTi, Trocar Tip
Published
2021-11-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
HXIPasser, Wire, Orthopedic

Product Code Classifications

CodeDeviceSpecialtyClass
HXIPasser, Wire, OrthopedicOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840200405539PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840200405539008402004055398402004055390840200405539

GMDN Terms

TermDefinition
Spinal procedural guidewireA flexible wire intended to facilitate percutaneous introduction of interventional (non-implantable) surgical devices (e.g., cannula) during spinal surgery. This is a single-use device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
800.201.9300customerservice@integrityimplants.com

Regulatory Flags

DUNS number
080300717
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
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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