ONE 17212D850

GUDID 03700483623174

MORIA SA

Corneal punch set
Primary Device ID03700483623174
NIH Device Record Key71342975-c21c-437e-8f56-4f611bcd8047
Commercial Distribution StatusIn Commercial Distribution
Brand NameONE
Version Model NumberONE-DEEP WELL GUARDED PUNCH D8.50 MM X1
Catalog Number17212D850
Company DUNS275937506
Company NameMORIA SA
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103700483610372 [Primary]
GS103700483623174 [Package]
Contains: 03700483610372
Package: [1 Units]
In Commercial Distribution

FDA Product Code

HNJPunch, Corneo-Scleral

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-05
Device Publish Date2023-12-28

On-Brand Devices [ONE]

03700483603329ONE - Punch D9.50mm x1
03700483600175ONE - Punch D9.00mm x1
03700483600168ONE - Punch D8.75mm x1
03700483600151ONE - Punch D8.50mm x1
03700483600144ONE - Punch D8.25mm x1
03700483600137ONE - Punch D8.00mm x1
03700483603312ONE - Punch D7.75mm x1
03700483603305ONE - Punch D7.50mm x1
03700483603299ONE - Punch D7.25mm x1
03700483603282ONE - Punch D7.00mm x1
03700483603855ONE - Punch D6.75mm x1
03700483603848ONE - Punch D6.50mm x1
03700483603831ONE - Punch D6.00mm x1
03700483625864XS PEDIATRIC WIRE SPECULUM
03700483625826ROP KIT S SPECULUM/LOOP DEPRESSOR
03700483625789ROP KIT XS SPECULUM/LOOP DEPRESSOR
03700483625741ROP KIT XS SPECULUM/2IN1 DEPRESSOR
03700483627141ROP KIT XS SPECULUM/2IN1 DEPRESSOR
03700483624812ONE-DEEP WELL FULL CUT D10.00MM X 1
03700483624775ONE-DEEP WELL FULL CUT D9.50MM X 1
03700483624737ONE-DEEP WELL FULL CUT D9.00MM X 1
03700483624690ONE-DEEP WELL FULL CUT D8.75MM X 1
03700483624652ONE-DEEP WELL FULL CUT D8.50MM X 1
03700483624614ONE-DEEP WELL FULL CUT D8.25MM X 1
03700483624577ONE-DEEP WELL FULL CUT D8.00MM X 1
03700483624539ONE-DEEP WELL FULL CUT D7.75MM X 1
03700483624492ONE-DEEP WELL FULL CUT D7.50MM X 1
03700483624454ONE-DEEP WELL FULL CUT D7.25MM X 1
03700483624416ONE-DEEP WELL FULL CUT D7.00MM X 1
03700483624379ONE-DEEP WELL FULL CUT D6.75MM X 1
03700483624331ONE-DEEP WELL FULL CUT D6.50MM X 1
03700483624294ONE-DEEP WELL FULL CUT D6.00MM X 1
03700483624256ONE-DEEP WELL GUARDED COVER D8.00MM X 1
03700483624218ONE-DEEP WELL GUARDED COVER D7.75MM X 1
03700483624171ONE-DEEP WELL GUARDED COVER D7.50MM X 1
03700483624133ONE-DEEP WELL TRI-FOLD COVER R8.00MM X 1
03700483624096ONE-DEEP WELL TRI-FOLD COVER R7.75MM X 1
03700483624058ONE-DEEP WELL TRI-FOLD COVER R7.50MM X 1
03700483622573ONE-SIEBEL MANIPULATOR X10
03700483622535ONE-LESTER MANIP. STRAIGHT X10
03700483620265One S-flat tying forceps curved x10
03700483620234One S-flat tying forceps angled x10
03700483620180One-pediatric wire speculum x10
03700483620166ROP exam kit W/WS -L x10
03700483620227One S-flat tying forceps angled x5
03700483603459ONE - ROP EXAM. KIT - L
03700483602230ONE-BORES MARKER, 12MM
03700483602223ONE-BORES MARKER, 12MM
03700483602216ONE-MENDEZ RING, 12MM
03700483602193ONE-TOR.IOL PRE-OP MARK BUBBLE LEVEL

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