Synergy E0016983-1

GUDID 00885556784419

PELVIS PIN

Smith & Nephew, Inc.

Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable
Primary Device ID00885556784419
NIH Device Record Keyb6b7cfdf-88eb-4d1b-9282-b20325ae35a2
Commercial Distribution StatusIn Commercial Distribution
Brand NameSynergy
Version Model NumberE0016983-1
Catalog NumberE0016983-1
Company DUNS109903521
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100885556784419 [Primary]
GS100885556784419 [Primary]
GS100885556784419 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, fixation, bone
HRSPlate, fixation, bone
HRSPlate, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00885556784419]

Moist Heat or Steam Sterilization


[00885556784419]

Moist Heat or Steam Sterilization


[00885556784419]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-19
Device Publish Date2020-05-11

On-Brand Devices [Synergy]

00885556739952TRIAL FEM HEAD WITH HOLES 32MM -3MM
00885556737774TRIAL FEM HEAD WITH HOLES 32MM -3MM
00885556737651TRIAL HEAD WITH TAPER 36MM -3
00885556737644TRIAL HEAD WITH TAPER 36MM +12
00885556737637TRIAL HEAD WITH TAPER 36MM +8
00885556737620TRIAL HEAD WITH TAPER 36MM +4
00885556737613TRIAL HEAD WITH TAPER 36MM +0
00885556736401FULLY TOOTHED BROACH OVERSIZED 18
00885556736395FULLY TOOTHED BROACH OVERSIZED 17
00885556736388FULLY TOOTHED BROACH OVERSIZED 16
00885556736371FULLY TOOTHED BROACH OVERSIZED 15
00885556736364FULLY TOOTHED BROACH OVERSIZED 14
00885556736357FULLY TOOTHED BROACH OVERSIZED 13
00885556736340FULLY TOOTHED BROACH OVERSIZED 12
00885556736333FULLY TOOTHED BROACH OVERSIZED 11
00885556736326FULLY TOOTHED BROACH OVERSIZED 10
00885556736319FULLY TOOTHED BROACH OVERSIZED 9
00885556730423MODIFIED SYNERGY BROACH SZ 18
00885556730416MODIFIED SYNERGY BROACH SZ 17
00885556730409MODIFIED SYNERGY BROACH SZ 16
00885556730393MODIFIED SYNERGY BROACH SZ 15
00885556730386MODIFIED SYNERGY BROACH SZ 14
00885556730379MODIFIED SYNERGY BROACH SZ 13
00885556730362MODIFIED SYNERGY BROACH SZ 12
00885556730355MODIFIED SYNERGY BROACH SZ 11
00885556730348MODIFIED SYNERGY BROACH SZ 10
00885556730331MODIFIED SYNERGY BROACH SZ 9
00885556730324MODIFIED SYNERGY BROACH SZ 8
00885556721148FULLY TOOTHED BROACH OVERSIZED 18
00885556721131FULLY TOOTHED BROACH OVERSIZED 17
00885556721124FULLY TOOTHED BROACH OVERSIZED 16
00885556721117FULLY TOOTHED BROACH OVERSIZED 15
00885556721100FULLY TOOTHED BROACH OVERSIZED 14
00885556721094FULLY TOOTHED BROACH OVERSIZED 13
00885556721087FULLY TOOTHED BROACH OVERSIZED 12
00885556721070FULLY TOOTHED BROACH OVERSIZED 11
00885556721063FULLY TOOTHED BROACH OVERSIZED 10
00885556721056FULLY TOOTHED BROACH OVERSIZED 9
00885556715543HIP INSERTER
00885556714898FULLY TOOTHED BROACH OVERSIZED 18
00885556714881FULLY TOOTHED BROACH OVERSIZED 17
00885556714874FULLY TOOTHED BROACH OVERSIZED 16
00885556714867FULLY TOOTHED BROACH OVERSIZED 15
00885556714850FULLY TOOTHED BROACH OVERSIZED 14
00885556714843FULLY TOOTHED BROACH OVERSIZED 13
00885556714836FULLY TOOTHED BROACH OVERSIZED 12
00885556714829FULLY TOOTHED BROACH OVERSIZED 11
00885556714812FULLY TOOTHED BROACH OVERSIZED 10
00885556714805FULLY TOOTHED BROACH OVERSIZED 9
00885556696798TRIAL FEM HEAD WITH HOLES - 32MM +8

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