DEVICE: BioScrew HyperFlex (10845854041697)

Device Identifier (DI) Information

BioScrew HyperFlex
C8006D
In Commercial Distribution
C8006D
Conmed Corporation
10845854041697
GS1

5
071595540 *Terms of Use
BIOSCREW HYPERFLEX GUIDEWIRE, NITINOL 14 IN, STERILE, 0.8 x 356 mm (.032 x 14 in)
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
62729 Orthopaedic guidewire, single-use
A 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.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
MDM INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: KEEP DRY
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 0.8 x 356 mm (.032 x 14 in.)
CLOSE

Device Record Status

e676e6d1-e99b-466f-9b0a-effa4f7d8a06
September 11, 2024
4
October 12, 2021
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
20845854041694 1 10845854041697 In Commercial Distribution CARTON
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: 00845854041690 CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(866)426-6633
CustomerExperience@conmed.com
CLOSE