FDA.report

NA

Primary DI
00840200404303
Brand
NA
Company
INTEGRITY IMPLANTS INC.
Model
CMP-02078
Catalog number
CMP-02078
Device description
Impact Pin - Navigation
Published
2021-04-28
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
true

Related Records

Contact Domains

Product Codes

CodeName
HXIPasser, Wire, Orthopedic

Product Code Classifications

CodeDeviceSpecialtyClass
HXIPasser, Wire, OrthopedicOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840200404303PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840200404303008402004043038402004043030840200404303

GMDN Terms

TermDefinition
Spinal guidewireA sterile flexible wire intended to facilitate percutaneous introduction of 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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