MID10BA50

GUDID 10888551003674

BUR FLUTED BALL LEGEND SYSTEM

STERILMED, INC.

Orthopaedic bur, single-use
Primary Device ID10888551003674
NIH Device Record Keycddac810-ce4d-4d7f-987f-d05297540501
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberMID10BA50
Catalog NumberMID10BA50
Company DUNS175899459
Company NameSTERILMED, 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 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(888)541-0078
Emailsterilmedcs@its.jnj.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110888551003674 [Primary]

FDA Product Code

GFFBUR, SURGICAL, GENERAL & PLASTIC SURGERY

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10888551003674]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-07
Device Publish Date2020-04-29

Devices Manufactured by STERILMED, INC.

10888551045179 - NA2021-10-20 REPROCESSED PENTARAY NAV ECO HIGH DENSITY MAPPING CATHETER, F CURVE
10888551045186 - NA2021-10-20 REPROCESSED PENTARAY NAV ECO HIGH DENSITY MAPPING CATHETER, D CURVE
10888551045193 - NA2021-10-20 REPROCESSED PENTARAY NAV ECO HIGH DENSITY MAPPING CATHETER, F CURVE
10888551045209 - NA2021-10-20 REPROCESSED PENTARAY NAV ECO HIGH DENSITY MAPPING CATHETER, D CURVE
10888551010313 - NA2021-01-22 KNIFE SET ECTRA II (PACK OF 3)
10888551021531 - NA2021-01-22 KNIVES (1) HOOK BLADE (1) TRIANGLE BLADE ENDOTRAC BLADE SYSTEM
10888551000048 - NA2020-11-06 CTS RELIEF KIT, 5PC SET
10888551012928 - NA2020-10-19 ENDO LUNG

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