FDA.report

Cannulated Headless Screw - Full Thread

Primary DI
00196449024247
Brand
Cannulated Headless Screw - Full Thread
Company
Tyber Medical, LLC
Model
03.333.017.01S
Device description
0.8MM GUIDE WIRE/100MM LENGTH DOUBLE TROCAR TIP, 1PK, STER
Published
2025-07-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
LXHOrthopedic manual surgical instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00196449024247PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00196449024247001964490242471964490242470196449024247

GMDN Terms

TermDefinition
Orthopaedic guidewire, single-useA thin, non-implantable rod designed to guide the insertion of a cannulated/tubular orthopaedic implant (typically an intramedullary nail, a bone screw or femoral fixation plate) and/or surgical instrument (e.g., drill bit) during an orthopaedic procedure. It is made of metal and is available in a variety of sizes, lengths, and designs (e.g., round-tip, trocar-tip, or flexible-tip). This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(866)761-0933ra@tybermed.com

Regulatory Flags

DUNS number
010968002
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00196449033669Anatomic Access LLIF810615182025-12-10
00196449033683Anatomic Access LLIF810815182025-12-10
00196449035007Anatomic Access LLIF811000072025-12-10
00196449035014Anatomic Access LLIF811100072025-12-10
00196449035021Anatomic Access LLIF811315072025-12-10
00196449035038Anatomic Access LLIF811415072025-12-10
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00196449035052Anatomic Access LLIF811615072025-12-10
00196449033836Anatomic Access LLIF811000052025-10-22
00196449033423Anatomic Access LLIF810100042025-12-02
00196449033430Anatomic Access LLIF810100062025-12-02
00196449033447Anatomic Access LLIF810100082025-12-02
00196449033478Anatomic Access LLIF810115062025-12-02
00196449033485Anatomic Access LLIF810115082025-12-02
00196449033492Anatomic Access LLIF810115102025-12-02
00196449033584Anatomic Access LLIF810200102025-12-02
00196449033607Anatomic Access LLIF810200222025-12-02
00196449033621Anatomic Access LLIF810300182025-12-02
00196449033645Anatomic Access LLIF810400182025-12-02

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