EMPERION 71361271

GUDID 03596010569400

EMPERION 19 SLEEVE INSERTER CONE

Smith & Nephew, Inc.

Orthopaedic implantation sleeve, reusable
Primary Device ID03596010569400
NIH Device Record Keybb97f70c-87b9-4786-a96f-1ff8a58afc7d
Commercial Distribution Discontinuation2018-03-28
Commercial Distribution StatusNot in Commercial Distribution
Brand NameEMPERION
Version Model Number71361271
Catalog Number71361271
Company DUNS045483575
Company NameSmith & Nephew, Inc.
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 Usefalse
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

Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS103596010569400 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPLATE, FIXATION, BONE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03596010569400]

Moist Heat or Steam Sterilization


[03596010569400]

Moist Heat or Steam Sterilization


[03596010569400]

Moist Heat or Steam Sterilization


[03596010569400]

Moist Heat or Steam Sterilization


[03596010569400]

Moist Heat or Steam Sterilization


[03596010569400]

Moist Heat or Steam Sterilization


[03596010569400]

Moist Heat or Steam Sterilization


[03596010569400]

Moist Heat or Steam Sterilization


[03596010569400]

Moist Heat or Steam Sterilization


[03596010569400]

Moist Heat or Steam Sterilization


[03596010569400]

Moist Heat or Steam Sterilization


[03596010569400]

Moist Heat or Steam Sterilization


[03596010569400]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-09-07
Device Publish Date2015-09-28

On-Brand Devices [EMPERION]

00885556311844EMPERION 15 STEM PRIMARY REDUCED OFFSET
00885556311790EMPERION 13 STEM PRIMARY REDUCED OFFSET
00885556143940EMPERION SLEEVE TRIAL 11MM MED CONE SLOTTED ASSY
00885556143933EMPERION SLEEVE TRIAL 11MM LG CONE SLOTTED ASSY
00885556111475EMP 19 SM CONE 1 SPOUT TRIAL SLEEVE
00885556066089EMPERION 19 STEM PRIMARY SO 18MM DISTAL
00885556065808EMPERION 17 STEM PRIMARY HO 16MM DISTAL
00885556065761EMPERION 17 STEM PRIMARY SO 16MM DISTAL
00885556065556EMPERION 15 STEM PRIMARY HO 14MM DISTAL
00885556065204EMPERION 15 STEM PRIMARY SO 14MM DISTAL
00885556064962EMPERION 13 STEM PRIMARY HO 12MM DISTAL
00885556064757EMPERION 13 STEM PRIMARY SO 12MM DISTAL
00885556064733EMPERION 11 STEM PRIMARY HO 10MM DISTAL
00885556064092EMPERION 19 STEM PRIMARY HO 18MM DISTAL
00885556064078EMPERION 11 STEM PRIMARY SO 10MM DISTAL
00885556060063EMPERION SLEEVE TRIAL 9MM LG CONE SLOTTED ASSY
00885556059845EMPERION SLEEVE 11 MED CONE SLOTTED
00885556059739EMPERION SLEEVE 11 SM CONE SLOTTED
00885556059678EMPERION SLEEVE TRIAL 9MM MED CONE SLOTTED ASSY
00885556059074EMPERION SLEEVE 13MM SM CONE SLOTTED
00885556059005EMPERION SLEEVE TRIAL 9MM SM CONE SLOTTED ASSY
00885556058985EMPERION SLEEVE 9 LG CONE SLOTTED
00885556058978EMPERION SLEEVE TRIAL 13MM LG CONE SLOTTED ASSY
00885556058640EMPERION SLEEVE TRIAL 13MM MED CONE SLOTTED ASSY
00885556058435EMPERION SLEEVE 9 MED CONE SLOTTED
00885556058411EMPERION SLEEVE 13MM LG CONE SLOTTED
00885556058336EMPERION SLEEVE TRIAL 13MM SM CONE SLOTTED ASSY
00885556058053EMPERION SLEEVE 13MM MED CONE SLOTTED
00885556057964EMPERION SLEEVE TRIAL 11MM SM CONE SLOTTED ASSY
00885556057902EMPERION SLEEVE 9 SM CONE SLOTTED
00885556057889EMPERION SLEEVE 11 LG CONE SLOTTED
0088555602894020.5 MM THIN SHAFT REAMER
00885556028889EMPERION 23 MED TALL TRIAL SLEEVE
0088555602853723 MM THIN SHAFT REAMER
00885556028452EMPERION 21 MED TALL TRIAL SLEEVE
00885556028230EMPERION 23S-21M TALL PROXIMAL REAMERS
0088555602782022.5 MM THIN SHAFT REAMER
00885556027813EMPERION 23XL PROXIMAL REAMERS
00885556027561EMPERION 21 SMALL TALL TRIAL SLEEVE
0088555602751622 MM THIN SHAFT REAMER
00885556027493EMPERION 23L-21XL PROXIMAL REAMERS
0088555602728821.5 MM THIN SHAFT REAMER
0088555602700424 MM THIN SHAFT REAMER
00885556026786EMPERION 22MM DISTAL REAMER
00885556026779EMPERION 23M TALL PROXIMAL REAMER
0088555602676223.5 MM THIN SHAFT REAMER
0088555602675521 MM THIN SHAFT REAMER
00885556026526EMPERION 23XL MILLER FRAME
00885556026410EMPERION 23MM MED BOWED TRIAL SLEEVE
00885556026373EMPERION 23L-21XL MILLER FRAME

Trademark Results [EMPERION]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EMPERION
EMPERION
98433478 not registered Live/Pending
Emperion, Inc.
2024-03-05
EMPERION
EMPERION
78481369 3110375 Dead/Cancelled
Smith & Nephew, Inc.
2004-09-10
EMPERION
EMPERION
74232017 1768231 Dead/Cancelled
Emperion Corporation
1991-12-20

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