FDA.report

DRIVEMEDICAL

Primary DI
00050428267653
Brand
DRIVEMEDICAL
Company
Drive Devilbiss Healthcare
Model
903291
Device description
Canes & CrutchesCrutches Product Description: Universal Quick Adjust Crutch,8pr/cs
Published
2019-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
IPRCRUTCH

Product Code Classifications

CodeDeviceSpecialtyClass
IPRCrutchPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00050428267653PackageGS18In Commercial Distribution
50050428442154PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00050428267653000504282676530504282676530050428267653
5005042844215450050428442154

GMDN Terms

TermDefinition
Walking aid handgripA device designed to help a person using a walking aid to grasp the walking aid (e.g., a walking stick, cane, crutch, walking frame or rollator) securely. Included are adjustable grips, grips with antislip material and grips of special material such as foam. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
867673159
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00822383012186Silver Sport 18" Full ArmSSP18RBDFAV2026-02-03
00822383012193Silver Sport 20" Det DeskSSP20RBDDAV2026-02-03
00822383012209Silver Sport 20" Full ArmSSP20RBDFAV2026-02-03
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00822383033228AeroFly Transport Chair, 18", BlackAFT18BK-SF2025-11-11
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