Avitus Orthopaedics

GUDID B504SRPC1000

Provision

Suturing unit, reprocessed
Primary Device IDB504SRPC1000
NIH Device Record Keyc52e2be3-86aa-4f3d-9fa7-82d80e0d2267
Commercial Distribution StatusIn Commercial Distribution
Brand NameAvitus Orthopaedics
Version Model NumberPC-100
Company DUNS016889401
Company NameProvision
Device Count1
DM Exempttrue
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
HIBCCB504SRPC1000 [Primary]

FDA Product Code

HWJAwl

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-26
Device Publish Date2023-05-18

On-Brand Devices [Avitus Orthopaedics]

B504SRPC1000PC-100
B504OMPC1000PC-100

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.