N/A SDH21A

GUDID 20705036003516

Straight Intraluminal Slapler (ILS) 16 Titanium Adjustable Height Staples

ETHICON ENDO-SURGERY, LLC

Intraluminal circular stapler, single-use Intraluminal circular stapler, single-use
Primary Device ID20705036003516
NIH Device Record Key02888901-cd31-4901-b125-2b2cff18be45
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model NumberSDH21A
Catalog NumberSDH21A
Company DUNS044606982
Company NameETHICON ENDO-SURGERY, LLC
Device Count3
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(877)384-4266
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4266
Emailcustomersupport@eesus.jnj.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110705036003519 [Unit of Use]
GS120705036003516 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GDWSTAPLE, IMPLANTABLE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-07-08
Device Publish Date2015-08-24

On-Brand Devices [N/A]

30705036009959CHOLECYSTECTOMY TRAY
30705036009942CHOLECYSTECTOMY TRAY
30705036009911CHOLECYSTECTOMY TRAY
30705036009904CHOLECYSTECTOMY TRAY
30705036009898CHOLECYSTECTOMY TRAY
30705036009881CHOLECYSTECTOMY TRAY
30705036009874CHOLECYSTECTOMY TRAY
30705036009867CHOLECYSTECTOMY TRAY
30705036009836CHOLECYSTECTOMY TRAY
30705036009812CHOLECYSTECTOMY TRAY
30705036009720BARIATRIC SURGERY TRAY
30705036009591BARIATRIC SURGERY TRAY
30705036009577BARIATRIC SURGERY TRAY
30705036009317BARIATRIC SURGERY TRAY
30705036008983ACCESS TRAY
30705036008976ACCESS TRAY
30705036008938ACCESS TRAY
30705036008921ACCESS TRAY
30705036008914ACCESS TRAY
30705036008877ACCESS TRAY
30705036008587CHOLECYSTECTOMY TRAY
30705036008518CHOLECYSTECTMY TRAY
30705036008457CHOLECYSTECTOMY TRAY
30705036008365CHOLECYSTECTOMY TRAY
30705036007702CHOLECYSTECTOMY TRAY
30705036007610CHOLECYSTECTOMY TRAY
30705036007603CHOLECYSTECTOMY TRAY
30705036007580CHOLECYSTECTOMY TRAY
30705036007573CHOLECYSTECTOMY TRAY
30705036007566CHOLECYSTECTOMY TRAY
30705036007399CHOLECYSTECTOMY TRAY
30705036007368CHOLECYSTECTOMY TRAY
30705036007283CHOLECYSTECTOMY TRAY
30705036007184CHOLECYSTECTOMY TRAY
30705036005517CHOLECYSTECTOMY TRAY
30705036005265CHOLECYSTECTOMY TRAY
30705036005258CHOLECYSTECTOMY TRAY
30705036005210CHOLECYSTECTOMY TRAY
30705036005180CHOLECYSTECTOMY TRAY
30705036005173CHOLECYSTECTOMY TRAY
20705036016059Thoracic VATS Lobectomy Kit
20705036016042Thoracic VATS Lobectomy Kit
20705036016035Thoracic VATS Lobectomy Kit
20705036016028Thoracic VATS Lobectomy Kit
20705036016011Thoracic VATS Lobectomy Kit
20705036016004Thoracic VATS Lobectomy/Segmentectomy Kit
20705036015991Thoracic VATS Lobectomy/Segmentectomy Kit
20705036015984Thoracic Segmentectomy Kit
20705036015977Colorectal Open Right Hemicolectomy Kit
20705036015960Colorectal Laparoscopic Right Hemicolectomy Kit

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