FDA.reportPublic FDA data

Alumi-Hand PLUS

Primary DI
00810045928784
Brand
Alumi-Hand PLUS
Company
INSTRUMENT SPECIALISTS, INC.
Model
KH-860-8
Catalog number
KH-860-8
Device description
The Alumi-Hand PLUS is a ready to use STERILE Hand Immobilizer offering new ways of holding the digits unlike any other Hand Immobilizer on the market. Made of pliable aluminum and foam, lead free, latex free and X-ray compatible. Patent Pending. Case of 8
Published
2023-06-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
CCXSupport, Patient Position

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCXSupport, Patient PositionAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810045928784PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810045928784008100459287848100459287840810045928784

GMDN Terms#

Term, Definition table
TermDefinition
Limb/torso/head restraint, single-useA non-rigid device, typically a strap(s), 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 single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
041517095
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810045921860Alumi-Hand PLUSKH-860-SingleKH-860-Single2023-06-01
00810045920009AlumiHandLarge760-8 Single2020-07-21
00810045920016AlumiHandExtra Large761-8 Single2020-07-21
00810045920023AlumiHandExtra Large761-8 2020-07-21
00810045920030AlumiHandLarge760-8 2020-07-21
00810045921631ISIS-HooksK32702020-07-30
00810045921655ISIStainless Steel Finger Traps w/Ball ChainK-3278-BC2020-07-30
00810045921662ISIStainless Steel Finger Traps w/Ball ChainK-3280-BC2020-07-30
00810045921679ISIStainless Steel Finger Traps w/Ball ChainK-3285-BC2020-07-30
00810045921686ISIStainless Steel Finger Traps w/Ball ChainK-3290-BC2020-07-30
00810045921693ISIStainless Steel Finger TrapsK33002020-07-30
00810045921709ISIStainless Steel Finger Traps w/Ball ChainK-3300-BC2020-07-30
00810045921716ISIFree StandingNT-37002020-07-30
00810045921723ISIFree StandingNT-37502020-07-30
00810045921730ISIFree StandingNT-CF-47502020-07-30
00810045921747ISIUltra-LightUL-80002020-07-30
00810045921754ISIUltra-LightUL-80502020-07-30
00810045921778ISIUltra-LightUL-81002020-07-30
00810045921785ISIUltra-LightUL-81502020-07-30
00810045921792ISIUltra-LightUL-82002020-07-30

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Primary DI, Brand, Company table
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00814247021311Panniculus Retraction Kit: traxi and ABBy - SmallCLINICAL INNOVATIONS, LLCCCX2026-05-31
00814247021328Panniculus Retraction Kit: traxi and ABBy - LargeCLINICAL INNOVATIONS, LLCCCX2026-05-31
10080196413737MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-04-27
10080196413256MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-03-30
10080196413485MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-03-30
10080196413690MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-03-30
07613327632842Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCCCX2025-11-19
07613327632859SageSAGE PRODUCTS, LLCCCX2025-11-19
07613327632866SageSAGE PRODUCTS, LLCCCX2025-11-19
07613327672718Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCCCX2025-11-19
10197344149834MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-22
10197344149803MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-12
10197344149810MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-12
10197344149827MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-12
G242SB03RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SB07SDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
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G242SS03DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
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G242SB05SDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SB10RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS01DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS04DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS05DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS08DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS10DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS11DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS15DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
10197344161034MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-07-28