FDA.report

In2Bones USA

Primary DI
00810021861333
Brand
In2Bones USA
Company
IN2BONES USA, LLC
Model
C01 N0017
Device description
DIP, CANNULATED REAMER, 2.7, Non-Sterile
Published
2019-07-31
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
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810021861333PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810021861333008100218613338100218613330810021861333

GMDN Terms

TermDefinition
Orthopaedic implant driverA hand-held manual surgical instrument designed to impart force to an orthopaedic implantable device that is inserted to fix or fasten together bones. The device is frequently used to insert devices such as screws, nails, plates, or wires that are used to fix fractured or damaged bones and/or to attach orthopaedic prostheses to the bones. It is typically made of high-grade stainless steel or titanium (Ti). 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

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30810175501094IBS-B MISS34 ST734S34 ST7342026-01-24
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30810175501117IBS-B MISS34 ST738S34 ST7382026-01-24
30810175501124IBS-B MISS34 ST740S34 ST7402026-01-24
30810175501131IBS-B MISS34 ST742S34 ST7422026-01-24
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30810175501155IBS-B MISS34 ST746S34 ST7462026-01-24
30810175501162IBS-B MISS34 ST748S34 ST7482026-01-24
30810175501179IBS-B MISS34 ST750S34 ST7502026-01-24
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