FDA.reportPublic FDA data

Forearm Crutches - Tall, 5'10" - 6'6"

Primary DI
00616784011219
Brand
Forearm Crutches - Tall, 5'10" - 6'6"
Company
Dynarex Corporation
Model
10112
Published
2019-09-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
IPRCrutch

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPRCrutchPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840117341500PackageGS11In Commercial Distribution
00616784011219PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117341500008401173415008401173415000840117341500
00616784011219006167840112196167840112190616784011219

GMDN Terms#

Term, Definition table
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.

Regulatory Flags#

DUNS number
008124539
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117305670Resp-O2 Closed Suction Tracheal Catheters, T-Piece, Adult/Pediatric310012021-04-22
00840117305694Resp-O2 Closed Suction Tracheal Catheter, T-Piece, Adult310022021-04-22
00840117305717Resp-O2 Closed Suction Tracheal Catheter, Double Swivel Elbow (DSE)310102021-04-22
00840117305731Resp-O2 Closed Suction Tracheal Catheter, Double Swivel Elbow (DSE)310112021-04-22
00840117305755Resp-O2 Closed Suction Tracheal Catheter, Double Swivel Elbow (DSE)310122021-04-22
00840117305779Resp-O2 Closed Suction Endotracheal Catheter, T-Piece, Adult/Pediatric310212021-04-22
00840117305786Resp-O2 Closed Suction Endotracheal Catheter, T-Piece, Adult310222021-04-22
00840117305809Resp-O2 Closed Suction Endotracheal Catheter, Double Swivel Elbow (DSE)310322021-04-22
00840117318144Resp-O2 Closed Suction Endotracheal Catheters, Sterile310202021-04-22
00840117318168Resp-O2 Closed Suction Endotracheal Catheter Double Swivel Elbow (DSE)310302021-04-22
00840117319462Resp-O2 Closed Suction Tracheal Catheter, T-Piece, Adult310032021-04-22
00840117319486Resp-O2 Closed Suction Tracheal Catheter, Double Swivel Elbow (DSE)310132021-04-22
00840117319523Resp-O2 Closed Suction Endotracheal Catheter, Double Swivel Elbow (DSE)310332021-04-22
00840117319547Resp-O2 Closed Suction Tracheal Catheters, T-Piece, Pediatric310002021-04-22
00840117344129Resp-O2 Vexta72 Closed Suction Tracheal Catheter, T-Piece, Pediatric310042025-10-27
00840117344204Resp-O2 Vexta72 Closed Suction Endotracheal Catheter, T-Piece, Pediatric310242026-05-18
00840117344211Resp-O2 Vexta72 Closed Suction Endotracheal Catheter, T-Piece, Adult/Pediatric310252026-05-18
00840117344228Resp-O2 Vexta72 Closed Suction Endotracheal Catheter, T-Piece, Adult310262026-05-18
00840117344242Resp-O2 Vexta72 Closed Suction Endotracheal Catheter, Double Swivel Elbow (DSE)310342026-05-18
00840117344259Resp-O2 Vexta72 Closed Suction Endotracheal Catheter, Double Swivel Elbow (DSE)310352026-05-18

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