FDA.report

In2Bones USA

Primary DI
00810021861173
Brand
In2Bones USA
Company
IN2BONES USA, LLC
Model
P06 N0241
Device description
5MS, JONES WIRE GUIDE, Ø2.2
Published
2019-06-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FZXGuide, Surgical, Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810021861173PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810021861173008100218611738100218611730810021861173

GMDN Terms

TermDefinition
Orthopaedic implantation sleeve, reusableA hand-held tubular surgical device designed to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw), facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smaller diameter sleeve) through it, stabilize an instrument/implant coupling, and/or protect the surgeon's gloved hand or patient tissue. It is not primarily intended to place, angle, and guide a rotating surgical drill. It is typically made of high-grade stainless steel and/or synthetic materials and is available in various sizes and lengths. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(866)426-6633CustomerExperience@conmed.com

Regulatory Flags

DUNS number
079700711
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
30810175501001IBS-B MISS34 ST716S34 ST7162026-01-24
30810175501018IBS-B MISS34 ST718S34 ST7182026-01-24
30810175501025IBS-B MISS34 ST720S34 ST7202026-01-24
30810175501032IBS-B MISS34 ST722S34 ST7222026-01-24
30810175501049IBS-B MISS34 ST724S34 ST7242026-01-24
30810175501056IBS-B MISS34 ST726S34 ST7262026-01-24
30810175501063IBS-B MISS34 ST728S34 ST7282026-01-24
30810175501070IBS-B MISS34 ST730S34 ST7302026-01-24
30810175501087IBS-B MISS34 ST732S34 ST7322026-01-24
30810175501094IBS-B MISS34 ST734S34 ST7342026-01-24
30810175501100IBS-B MISS34 ST736S34 ST7362026-01-24
30810175501117IBS-B MISS34 ST738S34 ST7382026-01-24
30810175501124IBS-B MISS34 ST740S34 ST7402026-01-24
30810175501131IBS-B MISS34 ST742S34 ST7422026-01-24
30810175501148IBS-B MISS34 ST744S34 ST7442026-01-24
30810175501155IBS-B MISS34 ST746S34 ST7462026-01-24
30810175501162IBS-B MISS34 ST748S34 ST7482026-01-24
30810175501179IBS-B MISS34 ST750S34 ST7502026-01-24
30810175501186IBS-B MISS34 ST752S34 ST7522026-01-24
30810175501193IBS-B MISS34 ST754S34 ST7542026-01-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08800200200079Drain-TGJSR MEDICAL CO., LTD.FZX2026-03-23
08800200200086Drain-TGJSR MEDICAL CO., LTD.FZX2026-03-23
00889024706965PSN 10MM M/L SHIFT BLOCKZimmer, Inc.FZX2026-03-19
03662663143462MaxAn Anterior Cervical Plate SystemHighridge Medical, LLCFZX2026-03-17
03662663143479MaxAn Anterior Cervical Plate SystemHighridge Medical, LLCFZX2026-03-17
03662663143486MaxAn Anterior Cervical Plate SystemHighridge Medical, LLCFZX2026-03-17
03662663143493MaxAn Anterior Cervical Plate SystemHighridge Medical, LLCFZX2026-03-17
03662663143509MaxAn Anterior Cervical Plate SystemHighridge Medical, LLCFZX2026-03-17
03662663143516MaxAn Anterior Cervical Plate SystemHighridge Medical, LLCFZX2026-03-17
03662663143523MaxAn Anterior Cervical Plate SystemHighridge Medical, LLCFZX2026-03-17
03662663143530MaxAn Anterior Cervical Plate SystemHighridge Medical, LLCFZX2026-03-17
00763000885212n/aMEDTRONIC SOFAMOR DANEK, INC.FZX2026-03-16
00840277133410Innomed, Inc.INNOMED, INC.FZX2026-03-11
10705034578866N/AMedos International SàrlFZX2026-03-05
10705034578873N/AMedos International SàrlFZX2026-03-05
10705034578880N/AMedos International SàrlFZX2026-03-05
10705034578897N/AMedos International SàrlFZX2026-03-05
00841435120402TecometTECOMET INC.FZX2026-02-27
09421038411889Adj Dist Fem Alignment Guide – CartilageENZTEC LIMITEDFZX2026-02-27
09421038411896Adj Dist Fem Alignment Guide – PaddleENZTEC LIMITEDFZX2026-02-27
09421038411902Sagittal Alignment Connector - PivotENZTEC LIMITEDFZX2026-02-27
09421038411919Sagittal Alignment Connector - Pivot with FanENZTEC LIMITEDFZX2026-02-27
09421038411926Dist Fem Cut Block Connector – 8mmENZTEC LIMITEDFZX2026-02-27
09421038411933Dist Fem Cut Block Connector – 9mmENZTEC LIMITEDFZX2026-02-27
09421038411940Dist Fem Cut Block Connector – 10mmENZTEC LIMITEDFZX2026-02-27
09421038411957Dist Fem Cut Block Slot Connector – 8mmENZTEC LIMITEDFZX2026-02-27
09421038411964Dist Fem Cut Block Slot Connector – 9mmENZTEC LIMITEDFZX2026-02-27
09421038411971Dist Fem Cut Block Slot Connector – 10mmENZTEC LIMITEDFZX2026-02-27
09421038411988Dist Fem Cut Block – 1.27mmENZTEC LIMITEDFZX2026-02-27
09421038411995IM Rod – 8mm x 135mmENZTEC LIMITEDFZX2026-02-27