47mm Single-Use Acetabular Reamer 11-100-0047

GUDID 00850032869126

Osteofit LLC

Bone-resection orthopaedic reamer, single-use
Primary Device ID00850032869126
NIH Device Record Keyb39d699d-aebb-40b6-bfc7-4afa33ee0c60
Commercial Distribution StatusIn Commercial Distribution
Brand Name47mm Single-Use Acetabular Reamer
Version Model Number11-100-0047
Catalog Number11-100-0047
Company DUNS020886963
Company NameOsteofit LLC
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

Phone862-210-8435
Emailjackie@osteofitllc.com
Phone862-210-8435
Emailjackie@osteofitllc.com
Phone862-210-8435
Emailjackie@osteofitllc.com
Phone862-210-8435
Emailjackie@osteofitllc.com
Phone862-210-8435
Emailjackie@osteofitllc.com
Phone862-210-8435
Emailjackie@osteofitllc.com
Phone862-210-8435
Emailjackie@osteofitllc.com
Phone862-210-8435
Emailjackie@osteofitllc.com
Phone862-210-8435
Emailjackie@osteofitllc.com
Phone862-210-8435
Emailjackie@osteofitllc.com
Phone862-210-8435
Emailjackie@osteofitllc.com
Phone862-210-8435
Emailjackie@osteofitllc.com
Phone862-210-8435
Emailjackie@osteofitllc.com
Phone862-210-8435
Emailjackie@osteofitllc.com
Phone862-210-8435
Emailjackie@osteofitllc.com
Phone862-210-8435
Emailjackie@osteofitllc.com
Phone862-210-8435
Emailjackie@osteofitllc.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850032869126 [Primary]

FDA Product Code

HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-14
Device Publish Date2023-12-06

Devices Manufactured by Osteofit LLC

00850032869072 - 51mm Single-Use Acetabular Reamer2023-12-14
00850032869089 - 53mm Single-Use Acetabular Reamer2023-12-14
00850032869096 - 55mm Single-Use Acetabular Reamer2023-12-14
00850032869102 - 57mm Single-Use Acetabular Reamer2023-12-14
00850032869119 - 45mm Single-Use Acetabular Reamer2023-12-14
00850032869126 - 47mm Single-Use Acetabular Reamer2023-12-14
00850032869126 - 47mm Single-Use Acetabular Reamer2023-12-14
00850032869133 - 49mm Single-Use Acetabular Reamer2023-12-14
00850032869003 - 46mm Single-Use Acetabular Reamer2022-08-12

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