FDA.report

Drive

Primary DI
00822383301587
Brand
Drive
Company
Drive Devilbiss Healthcare
Model
10403
Device description
Forearm Crutch, Adult, 1pr/bx
Published
2017-05-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
IPRCRUTCH

Product Code Classifications

CodeDeviceSpecialtyClass
IPRCrutchPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00822383301587PackageGS16In Commercial Distribution
00822383101583PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00822383301587008223833015878223833015870822383301587
00822383101583008223831015838223831015830822383101583

GMDN Terms

TermDefinition
Forearm support crutchA staff-like mobility aid used to assist a person with a disability to support their weight while walking. The device has one or more legs and a padded support or "trough" in a horizontal position for the user to rest the forearm. The hand wraps around a grip at the end of the forearm support. The device may be adjustable in length and is typically made of metal [e.g., aluminium (Al), titanium (Ti)]. This device is particularly suited to individuals who cannot rest their weight on their hands.

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
false
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
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00822383033211AeroFly Wheelchair 20:, Gray, SFAF20FDAGY-SF2025-11-11
00822383033228AeroFly Transport Chair, 18", BlackAFT18BK-SF2025-11-11
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