5.2 x 48mm Screw Fastener ST 352-1048

GUDID 00816950029127

5.2 x 48mm Screw Fastener ST

SMV SCIENTIFIC LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID00816950029127
NIH Device Record Keyf23d8960-b2a2-4a2b-bff5-27f2690506b3
Commercial Distribution StatusIn Commercial Distribution
Brand Name5.2 x 48mm Screw Fastener ST
Version Model Number352-1048
Catalog Number352-1048
Company DUNS089645059
Company NameSMV SCIENTIFIC LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com

Device Dimensions

Outer Diameter5.2 Millimeter
Length48 Millimeter
Outer Diameter5.2 Millimeter
Length48 Millimeter
Outer Diameter5.2 Millimeter
Length48 Millimeter
Outer Diameter5.2 Millimeter
Length48 Millimeter
Outer Diameter5.2 Millimeter
Length48 Millimeter
Outer Diameter5.2 Millimeter
Length48 Millimeter
Outer Diameter5.2 Millimeter
Length48 Millimeter
Outer Diameter5.2 Millimeter
Length48 Millimeter
Outer Diameter5.2 Millimeter
Length48 Millimeter
Outer Diameter5.2 Millimeter
Length48 Millimeter
Outer Diameter5.2 Millimeter
Length48 Millimeter
Outer Diameter5.2 Millimeter
Length48 Millimeter
Outer Diameter5.2 Millimeter
Length48 Millimeter
Outer Diameter5.2 Millimeter
Length48 Millimeter
Outer Diameter5.2 Millimeter
Length48 Millimeter
Outer Diameter5.2 Millimeter
Length48 Millimeter
Outer Diameter5.2 Millimeter
Length48 Millimeter
Outer Diameter5.2 Millimeter
Length48 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100816950029127 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDODevice, Fixation, Proximal Femoral, Implant

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816950029127]

Moist Heat or Steam Sterilization


[00816950029127]

Moist Heat or Steam Sterilization


[00816950029127]

Moist Heat or Steam Sterilization


[00816950029127]

Moist Heat or Steam Sterilization


[00816950029127]

Moist Heat or Steam Sterilization


[00816950029127]

Moist Heat or Steam Sterilization


[00816950029127]

Moist Heat or Steam Sterilization


[00816950029127]

Moist Heat or Steam Sterilization


[00816950029127]

Moist Heat or Steam Sterilization


[00816950029127]

Moist Heat or Steam Sterilization


[00816950029127]

Moist Heat or Steam Sterilization


[00816950029127]

Moist Heat or Steam Sterilization


[00816950029127]

Moist Heat or Steam Sterilization


[00816950029127]

Moist Heat or Steam Sterilization


[00816950029127]

Moist Heat or Steam Sterilization


[00816950029127]

Moist Heat or Steam Sterilization


[00816950029127]

Moist Heat or Steam Sterilization


[00816950029127]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-14
Device Publish Date2021-05-06

Devices Manufactured by SMV SCIENTIFIC LLC

00810074300001 - 4.0 x 12mm Screw Super Fastener, ST2023-06-20 4.0 x 12mm Screw Super Fastener, ST
00810074300018 - 4.0 x 14mm Screw Super Fastener, ST2023-06-20 4.0 x 14mm Screw Super Fastener, ST
00810074300025 - 4.0 x 16mm Screw Super Fastener, ST2023-06-20 4.0 x 16mm Screw Super Fastener, ST
00810074300032 - 4.0 x 18mm Screw Super Fastener, ST2023-06-20 4.0 x 18mm Screw Super Fastener, ST
00810074300049 - 4.0 x 20mm Screw Super Fastener, ST2023-06-20 4.0 x 20mm Screw Super Fastener, ST
00810074300056 - 4.0 x 22mm Screw Super Fastener, ST2023-06-20 4.0 x 22mm Screw Super Fastener, ST
00810074300063 - 4.0 x 24mm Screw Super Fastener, ST2023-06-20 4.0 x 24mm Screw Super Fastener, ST
00810074300070 - 4.0 x 26mm Screw Super Fastener, ST2023-06-20 4.0 x 26mm Screw Super Fastener, ST

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.