FDA.reportPublic FDA data

CLARITY® LATERAL RETRACTOR SYSTEM

Primary DI
00846468011369
Brand
CLARITY® LATERAL RETRACTOR SYSTEM
Company
Pioneer Surgical Technology, Inc.
Model
38-GW-CADDY-450
Device description
GUIDEWIRE CADDY
Published
2016-06-16
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRPTRAY, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846468011369PrimaryGS10
00846468098797PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846468011369008464680113698464680113690846468011369
00846468098797008464680987978464680987970846468098797

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(386)418-8888labeling@rtix.com
+1(906)226-9909labeling@resolvesurg.com
+1(906)226-9909regulatory@exalta.com

Regulatory Flags#

DUNS number
793384496
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840298701902CODA™ Anterior Cervical Plate System58-2022010102022-01-0102023-01-19
00840298701971CODA™ Anterior Cervical Plate System58-2022010242022-01-0242023-01-19
00840298702039CODA™ Anterior Cervical Plate System58-2022020282022-02-0282023-01-19
00840298702268CODA™ Anterior Cervical Plate System58-2022040802022-04-0802023-01-19
00840298700134CODA™ Anterior Cervical Plate System58-202221018S2022-21-018S2023-01-19
00840298700028CODA™ Anterior Cervical Plate System58-202220014S2022-20-014S2023-01-19
00840298700110CODA™ Anterior Cervical Plate System58-202221014S2022-21-014S2023-01-19
00840298700677CODA™ Anterior Cervical Plate System58-2022302002022-30-2002023-01-24
00840298701957CODA™ Anterior Cervical Plate System58-2022010202022-01-0202023-01-19
00840298702022CODA™ Anterior Cervical Plate System58-2022020262022-02-0262023-01-19
00840298702251CODA™ Anterior Cervical Plate System58-2022040762022-04-0762023-01-19
00840298700608CODA™ Anterior Cervical Plate System58-2022222002022-22-2002023-01-24
00840298700776CODA™ Anterior Cervical Plate System58-2022100072022-10-0072023-01-25
00840298700905CODA™ Anterior Cervical Plate System58-2022207172022-20-7172023-01-19
00840298701933CODA™ Anterior Cervical Plate System58-2022010162022-01-0162023-01-19
00840298701988CODA™ Anterior Cervical Plate System58-2022010262022-01-0262023-01-19
00840298702091CODA™ Anterior Cervical Plate System58-2022020402022-02-0402023-01-19
00840298702114CODA™ Anterior Cervical Plate System58-2022020442022-02-0442023-01-19
00840298702138CODA™ Anterior Cervical Plate System58-2022030452022-03-0452023-01-19
00840298702176CODA™ Anterior Cervical Plate System58-2022030572022-03-0572023-01-19

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Primary DI, Brand, Company table
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