IVRO RETRACTOR, SLIDER WITH TWO KNOBS

GUDID D928910140010

W.H. Holden, Inc.

Surgical drill guide, reusable
Primary Device IDD928910140010
NIH Device Record Keyed15ac07-fd09-4ce7-8ab4-db8c9b4bdc5a
Commercial Distribution StatusIn Commercial Distribution
Brand NameIVRO RETRACTOR, SLIDER WITH TWO KNOBS
Version Model Number91-0140-01
Company DUNS183854322
Company NameW.H. Holden, 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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD928910140010 [Primary]

FDA Product Code

FZXGuide, Surgical, Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D928910140010]

Moist Heat or Steam Sterilization


[D928910140010]

Moist Heat or Steam Sterilization


[D928910140010]

Moist Heat or Steam Sterilization


[D928910140010]

Moist Heat or Steam Sterilization


[D928910140010]

Moist Heat or Steam Sterilization


[D928910140010]

Moist Heat or Steam Sterilization


[D928910140010]

Moist Heat or Steam Sterilization


[D928910140010]

Moist Heat or Steam Sterilization


[D928910140010]

Moist Heat or Steam Sterilization


[D928910140010]

Moist Heat or Steam Sterilization


[D928910140010]

Moist Heat or Steam Sterilization


[D928910140010]

Moist Heat or Steam Sterilization


[D928910140010]

Moist Heat or Steam Sterilization


[D928910140010]

Moist Heat or Steam Sterilization


[D928910140010]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-02
Device Publish Date2025-04-24

Devices Manufactured by W.H. Holden, Inc.

D928104107DLC0 - ELEVATOR #107 DLC2025-05-29
D928104108DLC0 - ELEVATOR #108 DLC2025-05-29
D9281050890 - TRAY KNIFE2025-05-29
D92810519910BHD0 - BOSACK PACKER 4mm-6mm HD2025-05-29
D928105957CH0 - CURETTE SMILER #57 CH D/E MOLT 4 ANGLED & HENAHAN 1 ANGLED2025-05-29
D92810613410 - SUCTION TIP THREADED #4 W/ HOLE2025-05-29
D92820001580 - BAUER GUARDED OSTEO 8MM STR2025-05-29
D9282000451T0 - RAMUS RETRACTOR FLAT BLADE, DOWN 13x70mm WITH NOTCH2025-05-29

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.