FDA.report

AlumiHand

Primary DI
00810045920030
Brand
AlumiHand
Company
INSTRUMENT SPECIALISTS, INC.
Model
Large
Catalog number
760-8
Device description
The Alumi-Hand is the unique, ready-to-use hand immobilizer. Sterile and disposable, the Alumi-Hand is ready to go. Made of aluminum, the Alumi-Hand is Lead-Free, Latex-Free, and X-ray compatible. Box or 8
Published
2020-07-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
CCXSupport, Patient Position

Product Code Classifications

CodeDeviceSpecialtyClass
CCXSupport, Patient PositionAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810045920030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810045920030008100459200308100459200300810045920030

GMDN Terms

TermDefinition
Limb/torso/head restraint, reusableA non-rigid device, typically a strap(s) or band(s) or garment-like, intended to be temporarily placed on or around one or more parts of a patient’s body (e.g., torso, limbs, head) to restrict movement, to facilitate patient positioning and stabilization during a medical procedure, and/or to prevent injury/hazards while potentially permitting limited movement. It is made of various materials (e.g., fabric, nylon, leather, or foam) and typically anchored to a fixture or furniture part (e.g., a bedrail, operating table). It is not intended for immobilization of specific joint. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
041517095
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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00810045921747ISIUltra-LightUL-80002020-07-30
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00810045921792ISIUltra-LightUL-82002020-07-30
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00810045921822ISIUltra-LightUL-SB-90002020-07-30
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