FDA.reportPublic FDA data

Custom Medical Specialties, Inc.

Primary DI
00815849020122
Brand
Custom Medical Specialties, Inc.
Company
CUSTOM ASSEMBLIES, INC.
Model
CMS-203
Device description
Velcrow Quick Strap - Non-Sterile
Published
2016-11-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KIDRestraint, Wheelchair, Non-Protective

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KIDRestraint, Wheelchair, Non-ProtectivePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815849020122PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815849020122008158490201228158490201220815849020122

GMDN Terms#

Term, Definition table
TermDefinition
Limb/torso/head restraint, single-useA non-rigid device, typically a strap(s) or band(s), 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. 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
948904735
Device count
1
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815849020160Custom Medical Specialties, Inc.CMS-5102016-11-21
00815849020177Custom Medical Specialties, Inc.CMS-5152016-11-21
00815849021556Custom Medical Specialties, Inc.CMS-1637-NS2016-11-21
00815849021839Custom Medical Specialties, Inc.CMS-5862016-11-21
00815849024021Custom Medical Specialties, Inc. CMS-2732-R42023-09-14
00815849024571Custom Medical Specialties, Inc. CMS-6314-R62023-09-14
00815849023369Custom Medical Specialties, Inc. CMS-12352023-09-13
00815849023390Custom Medical Specialties, Inc. CMS-12382023-09-13
00815849023406PG-1000PG-10002023-09-13
00815849023437Custom Assemblies, Inc. CMS-2012-R32023-09-13
00815849023444Custom Assemblies, Inc. CMS-8322-R12023-09-13
00815849023451Custom Medical Specialties, Inc. CMS-5650-R22023-09-13
00815849023468Custom Medical Specialties, Inc. CMS-63822023-09-13
00815849023475Custom Medical Specialties, Inc. CMS-6439-C2023-09-13
00815849023482MPMMPM-312-R12023-09-13
00815849023499Custom Medical Specialties, Inc. CMS-1911-R32023-09-13
00815849023505MPMMPM-2952023-09-13
00815849023512Custom Medical Specialties, Inc. CMS-2450-R42023-09-13
00815849023529Custom Medical Specialties, Inc. CMS-4439-R52023-09-13
00815849023536Custom Medical Specialties, Inc. CMS-6803-R12023-09-13

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Primary DI, Brand, Company table
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00858101008339Small Right Arm AnchorRIFTON EQUIPMENTKID2022-09-16
00858101008346Wrist AnchorRIFTON EQUIPMENTKID2022-09-16
00858101008353Large Right Arm AnchorRIFTON EQUIPMENTKID2022-09-16
00858101008360Large Left Arm AnchorRIFTON EQUIPMENTKID2022-09-16
00858101008377Small Left Arm AnchorRIFTON EQUIPMENTKID2022-09-16
00858101008384Right Elbow AnchorRIFTON EQUIPMENTKID2022-09-16
00858101008391Left Elbow AnchorRIFTON EQUIPMENTKID2022-09-16
00858101008407Hand AnchorRIFTON EQUIPMENTKID2022-09-16
00858101008414Horizontal AnchorRIFTON EQUIPMENTKID2022-09-16
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00749756011549DeRoyalDEROYAL INDUSTRIES, INC.KID2021-08-03
00749756011563DeRoyalDEROYAL INDUSTRIES, INC.KID2021-08-03
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00749756111515DeRoyalDEROYAL INDUSTRIES, INC.KID2021-08-03
00749756112345DeRoyalDEROYAL INDUSTRIES, INC.KID2021-08-03
00749756128964DeRoyalDEROYAL INDUSTRIES, INC.KID2021-08-03
00749756780162DeRoyalDEROYAL INDUSTRIES, INC.KID2021-08-03
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