AWL/TAPPER 4.5MM 50AWLT45

GUDID 00850005827412

AWL/TAPPER 4.5MM

Genesis Biologics, Inc.

Bone tap, reusable
Primary Device ID00850005827412
NIH Device Record Key4074ba9e-f5c0-41e4-8fda-a9a472fecdb5
Commercial Distribution StatusIn Commercial Distribution
Brand NameAWL/TAPPER 4.5MM
Version Model Number50AWLT45
Catalog Number50AWLT45
Company DUNS016463487
Company NameGenesis Biologics, 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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone657-888-6243
EmailORDERS@GENESISBIOLOGICS.COM
Phone657-888-6243
EmailORDERS@GENESISBIOLOGICS.COM
Phone657-888-6243
EmailORDERS@GENESISBIOLOGICS.COM
Phone657-888-6243
EmailORDERS@GENESISBIOLOGICS.COM
Phone657-888-6243
EmailORDERS@GENESISBIOLOGICS.COM
Phone657-888-6243
EmailORDERS@GENESISBIOLOGICS.COM
Phone657-888-6243
EmailORDERS@GENESISBIOLOGICS.COM
Phone657-888-6243
EmailORDERS@GENESISBIOLOGICS.COM
Phone657-888-6243
EmailORDERS@GENESISBIOLOGICS.COM
Phone657-888-6243
EmailORDERS@GENESISBIOLOGICS.COM
Phone657-888-6243
EmailORDERS@GENESISBIOLOGICS.COM
Phone657-888-6243
EmailORDERS@GENESISBIOLOGICS.COM
Phone657-888-6243
EmailORDERS@GENESISBIOLOGICS.COM
Phone657-888-6243
EmailORDERS@GENESISBIOLOGICS.COM
Phone657-888-6243
EmailORDERS@GENESISBIOLOGICS.COM
Phone657-888-6243
EmailORDERS@GENESISBIOLOGICS.COM
Phone657-888-6243
EmailORDERS@GENESISBIOLOGICS.COM

Device Dimensions

Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100850005827412 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850005827412]

Moist Heat or Steam Sterilization

[00850005827412]

Moist Heat or Steam Sterilization

[00850005827412]

Moist Heat or Steam Sterilization

[00850005827412]

Moist Heat or Steam Sterilization

[00850005827412]

Moist Heat or Steam Sterilization

[00850005827412]

Moist Heat or Steam Sterilization

[00850005827412]

Moist Heat or Steam Sterilization

[00850005827412]

Moist Heat or Steam Sterilization

[00850005827412]

Moist Heat or Steam Sterilization

[00850005827412]

Moist Heat or Steam Sterilization

[00850005827412]

Moist Heat or Steam Sterilization

[00850005827412]

Moist Heat or Steam Sterilization

[00850005827412]

Moist Heat or Steam Sterilization

[00850005827412]

Moist Heat or Steam Sterilization

[00850005827412]

Moist Heat or Steam Sterilization

[00850005827412]

Moist Heat or Steam Sterilization

[00850005827412]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-16
Device Publish Date2024-10-08

Devices Manufactured by Genesis Biologics, Inc.

00850005827368 - AlternatiV+ Screw-In Anchor2024-10-16 4.75MM SCREW-IN SUTURE ANCHOR
00850005827375 - AlternatiV+ Screw-In Anchor2024-10-16 5.5MM SCREW-IN SUTURE ANCHOR
00850005827382 - AlternatiV+ Max Knotless Anchor2024-10-16 4.75MM MAX KNOTLESS ANCHOR
00850005827399 - DUAL PITCH AWL/TAPPER 4.75MM2024-10-16 DUAL PITCH AWL/TAPPER 4.75MM
00850005827405 - DUAL PITCH AWL/TAPPER 5.5MM2024-10-16 DUAL PITCH AWL/TAPPER 5.5MM
00850005827412 - AWL/TAPPER 4.5MM2024-10-16AWL/TAPPER 4.5MM
00850005827412 - AWL/TAPPER 4.5MM2024-10-16 AWL/TAPPER 4.5MM
00850005827429 - AWL 4.5MM2024-10-16 AWL 4.5MM
00850005827436 - AWL 5.5MM2024-10-16 AWL 5.5MM
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