52856B

GUDID 00885556909393

Cup Impactor - Offset

Smith & Nephew, Inc.

Orthopaedic prosthesis implantation positioning instrument, reusable
Primary Device ID00885556909393
NIH Device Record Key4efc0d07-6791-4afb-8b6d-be55a096a8c2
Commercial Distribution StatusIn Commercial Distribution
Version Model Number52856B
Catalog Number52856B
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 Batchfalse
Serial Numbertrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100885556909393 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic stereotaxic instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00885556909393]

Moist Heat or Steam Sterilization


[00885556909393]

Moist Heat or Steam Sterilization


[00885556909393]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-10-02
Device Publish Date2025-09-24

Devices Manufactured by Smith & Nephew, Inc.

00885556909393 - NA2025-10-02Cup Impactor - Offset
00885556909393 - NA2025-10-02 Cup Impactor - Offset
00885556906941 - EVOS2025-10-01 EVOS PELVIC 3.5MM LOCKING CURVED RECON PLATE 10 HOLE
00885556907207 - EVOS2025-10-01 EVOS PELVIC 2.7MM SHORT SEGMENT CURVED UTILITY PLATE
00885556907214 - EVOS2025-10-01 EVOS PELVIC 2.7/3.5MM SHORT SEGMENT CURVED UTILITY PLATE 2 HOLE
00885556907221 - EVOS2025-10-01 EVOS PELVIC 2.7/3.5MM SHORT SEGMENT CURVED UTILITY PLATE 4 HOLE
00885556907245 - EVOS2025-10-01 EVOS PELVIC 3.5MM SYMPHYSIS NON-LOCKING PLATE STANDARD 6 HOLE
00885556907252 - EVOS2025-10-01 EVOS PELVIC 3.5MM SYMPHYSIS NON-LOCKING PLATE STANDARD 8 HOLE
00885556907290 - EVOS2025-10-01 EVOS PELVIC 2.7MM/3.5MM SYMPHYSIS LOCKING PLATE TABBED 4 HOLE

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