Stat-A-Dyne Wrist Wrist

GUDID B770WR0

Orthosis providing flexion and extension of wrist

LANTZ MEDICAL, INC.

Wrist orthosis
Primary Device IDB770WR0
NIH Device Record Key8efac191-0fdb-4be8-8a6d-a7a22e331d72
Commercial Distribution StatusIn Commercial Distribution
Brand NameStat-A-Dyne Wrist
Version Model NumberWrist
Catalog NumberWrist
Company DUNS614335276
Company NameLANTZ MEDICAL, 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 Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB770WR0 [Primary]

FDA Product Code

IQIOrthosis, Limb Brace

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-15
Device Publish Date2023-06-07

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