FDA.report

Cortera

Primary DI
00840311209439
Brand
Cortera
Company
Surgalign Spine Technologies, Inc.
Model
1506-2960550
Device description
Guidewire, SS, Threaded Tip, 550
Published
2023-01-06
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
false

Related Records

Contact Domains

Product Codes

CodeName
LXHOrthopedic manual surgical instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840311209439PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840311209439008403112094398403112094390840311209439

GMDN Terms

TermDefinition
Spinal guidewireA thin, non-implantable rod intended to guide the insertion of a cannulated orthopaedic implant (typically a screw) and/or surgical instrument (e.g., cannula, drill bit) during spinal surgery. This is a single-use device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(844)894-7752customerservice@surgalign.com

Regulatory Flags

DUNS number
014520584
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00810076562230Cortera150100-400652023-01-06
00810076562247Cortera150100-400702023-01-06
00810076562254Cortera150100-400752023-01-06
00810076562261Cortera150100-400802023-01-06
00810076562278Cortera150100-400852023-01-06
00810076562285Cortera150100-400902023-01-06
00810076562292Cortera150100-400952023-01-06
00810076562308Cortera150100-401002023-01-06
00810076562315Cortera150100-401052023-01-06
00810076562322Cortera150100-401102023-01-06
00810076562339Cortera150100-401152023-01-06
00810076562346Cortera150100-401202023-01-06
00810076562438Cortera150100-450652023-01-06
00810076562445Cortera150100-450702023-01-06
00810076562452Cortera150100-450752023-01-06
00810076562469Cortera150100-450802023-01-06
00810076562476Cortera150100-450852023-01-06
00810076562483Cortera150100-450902023-01-06
00810076562490Cortera150100-450952023-01-06
00810076562506Cortera150100-451002023-01-06

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