FDA.reportPublic FDA data

Zimmer® Cannulated Screw System

Primary DI
00846468074654
Brand
Zimmer® Cannulated Screw System
Company
Pioneer Surgical Technology, Inc.
Model
00-1147-099-02
Catalog number
00-1147-099-02
Device description
GUIDE PIN, 3.2mm X 295mm SMOOTH SHAFT TROC TIP
Published
2020-09-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846468074654PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846468074654008464680746548464680746540846468074654

GMDN Terms#

Term, Definition table
TermDefinition
General external orthopaedic fixation system implantation kit, single-useA collection of non-sterile, manual surgical instruments intended to be used for the placement of an external orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It includes various instruments [e.g., retractors, rods, clamps, drills, pins/screws, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of external orthopaedic fixation system (i.e., non-dedicated); it does not include any implantable devices. This is a single-use 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
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00840298703685CODA™ Anterior Cervical Plate System58-202230010S2022-30-010S2023-06-28
00840298703708CODA™ Anterior Cervical Plate System58-202230014S2022-30-014S2023-06-28
00840298701445CODA™ Anterior Cervical Plate System58-102201010S1022-01-010S2023-06-26
00840298701452CODA™ Anterior Cervical Plate System58-102201012S1022-01-012S2023-06-26
00840298701469CODA™ Anterior Cervical Plate System58-102201014S1022-01-014S2023-06-26
00840298701476CODA™ Anterior Cervical Plate System58-102201016S1022-01-016S2023-06-26
00840298701490CODA™ Anterior Cervical Plate System58-102201020S1022-01-020S2023-06-26
00840298701506CODA™ Anterior Cervical Plate System58-102201022S1022-01-022S2023-06-26
00840298701520CODA™ Anterior Cervical Plate System58-102201026S1022-01-026S2023-06-26
00840298701537CODA™ Anterior Cervical Plate System58-102201028S1022-01-028S2023-06-26
00840298701544CODA™ Anterior Cervical Plate System58-102201030S1022-01-030S2023-06-26
00840298701568CODA™ Anterior Cervical Plate System58-102202026S1022-02-026S2023-06-26
00840298701582CODA™ Anterior Cervical Plate System58-102202030S1022-02-030S2023-06-26
00840298701599CODA™ Anterior Cervical Plate System58-102202032S1022-02-032S2023-06-26
00840298701605CODA™ Anterior Cervical Plate System58-102202034S1022-02-034S2023-06-26
00840298701612CODA™ Anterior Cervical Plate System58-102202036S1022-02-036S2023-06-26
00840298701629CODA™ Anterior Cervical Plate System58-102202038S1022-02-038S2023-06-26
00840298701636CODA™ Anterior Cervical Plate System58-102202040S1022-02-040S2023-06-26
00840298701643CODA™ Anterior Cervical Plate System58-102202042S1022-02-042S2023-06-26
00840298701650CODA™ Anterior Cervical Plate System58-102202044S1022-02-044S2023-06-26

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