DuraHand DH-100

GUDID 00810045920993

DuraHand, Pedi

INSTRUMENT SPECIALISTS, INC.

Limb/torso/head restraint, reusable Limb/torso/head restraint, reusable Limb/torso/head restraint, reusable Limb/torso/head restraint, reusable Limb/torso/head restraint, reusable Limb/torso/head restraint, reusable Limb/torso/head restraint, reusable Limb/torso/head restraint, reusable Limb/torso/head restraint, reusable Limb/torso/head restraint, reusable Limb/torso/head restraint, reusable Limb/torso/head restraint, reusable Limb/torso/head restraint, reusable Limb/torso/head restraint, reusable
Primary Device ID00810045920993
NIH Device Record Keya1614e8b-8457-4571-b4dc-92459a6ff7ad
Commercial Distribution StatusIn Commercial Distribution
Brand NameDuraHand
Version Model NumberDuraHand
Catalog NumberDH-100
Company DUNS041517095
Company NameINSTRUMENT SPECIALISTS, 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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810045920993 [Primary]
GS100810045920993 [Primary]
GS100810045920993 [Primary]
GS100810045920993 [Primary]
GS100810045920993 [Primary]
GS100810045920993 [Primary]
GS100810045920993 [Primary]
GS100810045920993 [Primary]
GS100810045920993 [Primary]
GS100810045920993 [Primary]
GS100810045920993 [Primary]
GS100810045920993 [Primary]
GS100810045920993 [Primary]
GS100810045920993 [Primary]

FDA Product Code

CCXSupport, Patient Position
CCXSupport, Patient Position
CCXSupport, Patient Position
CCXSupport, Patient Position
CCXSupport, Patient Position
CCXSupport, Patient Position
CCXSupport, Patient Position
CCXSupport, Patient Position
CCXSupport, Patient Position
CCXSupport, Patient Position
CCXSupport, Patient Position
CCXSupport, Patient Position
CCXSupport, Patient Position
CCXSupport, Patient Position

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810045920993]

Moist Heat or Steam Sterilization


[00810045920993]

Moist Heat or Steam Sterilization


[00810045920993]

Moist Heat or Steam Sterilization


[00810045920993]

Moist Heat or Steam Sterilization


[00810045920993]

Moist Heat or Steam Sterilization


[00810045920993]

Moist Heat or Steam Sterilization


[00810045920993]

Moist Heat or Steam Sterilization


[00810045920993]

Moist Heat or Steam Sterilization


[00810045920993]

Moist Heat or Steam Sterilization


[00810045920993]

Moist Heat or Steam Sterilization


[00810045920993]

Moist Heat or Steam Sterilization


[00810045920993]

Moist Heat or Steam Sterilization


[00810045920993]

Moist Heat or Steam Sterilization


[00810045920993]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-31
Device Publish Date2020-07-23

On-Brand Devices [DuraHand]

00810045921082DuraHand, Extra Large - Surgical Advantage
00810045921075DuraHand, Extra Large - Medical Products Resource
00810045921068DuraHand, Extra Large - Integra Life Sciences
00810045921051DuraHand, Extra Large
00810045921044DuraHand, Large - Surgical Advantage
00810045921037DuraHand, Large - Medical Products Resource
00810045921020DuraHand, Large - Integra Life Sciences
00810045921013DuraHand, Large
00810045921006DuraHand, Pedi - Medical Products Resource
00810045920993DuraHand, Pedi

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