PyroSphere CMC CSA-440-02

GUDID 00885556830710

PHS CASE

Smith & Nephew, Inc.

Instrument tray, reusable
Primary Device ID00885556830710
NIH Device Record Key453d98e9-7ac1-4004-9427-3c22a8a758e7
Commercial Distribution StatusIn Commercial Distribution
Brand NamePyroSphere CMC
Version Model NumberCSA-440-02
Catalog NumberCSA-440-02
Company DUNS045483575
Company NameSmith & Nephew, 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 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
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100885556830710 [Primary]

FDA Product Code

OJHOrthopedic tray

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00885556830710]

Moist Heat or Steam Sterilization


[00885556830710]

Moist Heat or Steam Sterilization


[00885556830710]

Moist Heat or Steam Sterilization


[00885556830710]

Moist Heat or Steam Sterilization


[00885556830710]

Moist Heat or Steam Sterilization


[00885556830710]

Moist Heat or Steam Sterilization


[00885556830710]

Moist Heat or Steam Sterilization


[00885556830710]

Moist Heat or Steam Sterilization


[00885556830710]

Moist Heat or Steam Sterilization


[00885556830710]

Moist Heat or Steam Sterilization


[00885556830710]

Moist Heat or Steam Sterilization


[00885556830710]

Moist Heat or Steam Sterilization


[00885556830710]

Moist Heat or Steam Sterilization


[00885556830710]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-09-07
Device Publish Date2022-12-22

On-Brand Devices [PyroSphere CMC]

00885556830734PCS IMPLANT EXTRACTOR
00885556830680SPHERICAL BURR SZ. 50
00885556830673SPHERICAL BURR SZ. 40
00885556830666SPHERICAL BURR SZ. 30
00885556830659SPHERICAL BURR SZ. 20
00885556830642SPHERICAL BURR SZ. 10
00885556830741PCS SZ. 10 PYROSPHERE
00885556830758PCS SZ. 20 PYROSPHERE
00885556830772PCS SZ. 40 PYROSPHERE
00885556830765PCS SZ. 30 PYROSPHERE
00885556830888PYROSPHERE TRIAL SZ. 50
00885556830871PYROSPHERE TRIAL SZ. 40
00885556830864PYROSPHERE TRIAL SZ. 30
00885556830857PYROSPHERE TRIAL SZ. 20
00885556830840PYROSPHERE TRIAL SZ. 10
00885556830789PCS SZ. 50 PYROSPHERE
00885556830727PHS CASE LID
00885556830710PHS CASE
00885556830703PCS INSTRUMENT CASE BASE
00885556830697PCS INSTRUMENT CASE LID

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