Exchange Tube SLN-T44

GUDID B058SLNT441

Guide Wire Exchange Tube

Orthopedic Designs North America, Inc.

Orthopaedic implantation sleeve, single-use
Primary Device IDB058SLNT441
NIH Device Record Key5099f896-6a00-43c1-ac4d-5f802bc112d4
Commercial Distribution StatusIn Commercial Distribution
Brand NameExchange Tube
Version Model NumberSLNT44
Catalog NumberSLN-T44
Company DUNS945518848
Company NameOrthopedic Designs North America, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB058SLNT441 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[B058SLNT441]

Moist Heat or Steam Sterilization


[B058SLNT441]

Moist Heat or Steam Sterilization


[B058SLNT441]

Moist Heat or Steam Sterilization


[B058SLNT441]

Moist Heat or Steam Sterilization


[B058SLNT441]

Moist Heat or Steam Sterilization


[B058SLNT441]

Moist Heat or Steam Sterilization


[B058SLNT441]

Moist Heat or Steam Sterilization


[B058SLNT441]

Moist Heat or Steam Sterilization


[B058SLNT441]

Moist Heat or Steam Sterilization


[B058SLNT441]

Moist Heat or Steam Sterilization


[B058SLNT441]

Moist Heat or Steam Sterilization


[B058SLNT441]

Moist Heat or Steam Sterilization


[B058SLNT441]

Moist Heat or Steam Sterilization


[B058SLNT441]

Moist Heat or Steam Sterilization


[B058SLNT441]

Moist Heat or Steam Sterilization


[B058SLNT441]

Moist Heat or Steam Sterilization


[B058SLNT441]

Moist Heat or Steam Sterilization


[B058SLNT441]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-14
Device Publish Date2023-07-06

Devices Manufactured by Orthopedic Designs North America, Inc.

B058CCD0912NS1 - Cannulated Compression Device (CCD) System2024-07-29 CCD Compression Nut - Compressive (non-sterile)
B058CCD0915NS1 - Cannulated Compression Device (CCD) System2024-07-29 CCD Compression Nut - Neutral (non-sterile)
B058CCD7516045NS1 - Cannulated Compression Device (CCD) System2024-07-29 Cannulated Compression Device - 045mm - 16mm (non-sterile)
B058CCD7516050NS1 - Cannulated Compression Device (CCD) System2024-07-29 Cannulated Compression Device - 050mm - 16mm (non-sterile)
B058CCD7516055NS1 - Cannulated Compression Device (CCD) System2024-07-29 Cannulated Compression Device - 055mm - 16mm (non-sterile)
B058CCD7516060NS1 - Cannulated Compression Device (CCD) System2024-07-29 Cannulated Compression Device - 060mm - 16mm (non-sterile)
B058CCD7516065NS1 - Cannulated Compression Device (CCD) System2024-07-29 Cannulated Compression Device - 065mm - 16mm (non-sterile)
B058CCD7516070NS1 - Cannulated Compression Device (CCD) System2024-07-29 Cannulated Compression Device - 070mm - 16mm (non-sterile)

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