FDA.reportPublic FDA data

Uni-Fit Extender™

Primary DI
00689281019224
Brand
Uni-Fit Extender™
Company
Healthcraft Products Inc.
Model
SP-UF
Catalog number
01922
Device description
"The Uni-Fit Extender is a high quality, commercial grade installation accessory to be used with the SuperPole. The Uni-Fit Extender is intended to increase the floor to ceiling range of the SuperPole from 93-99"" to 100-120"" (236-251cm to 254-305cm). The Uni-Fit Extender is a metal tube that attaches between the top plate and the pole assembly of the SuperPole. The Uni-Fit Extender features a series of holes that can be selected depending on the desired floor to ceiling height range. The Uni-Fit Extender is only to be used with HealthCraft’s SuperPole System. The Uni-Fit Extender is not to be used with the SuperTrapeze, SuperPole Bariatric or SuperPole Ultra. The Uni-Fit Extender is not to be used in any other way than described. "
Published
2021-08-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FMRDevice, Transfer, Patient, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMRDevice, Transfer, Patient, ManualGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00689281019224PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00689281019224006892810192246892810192240689281019224

GMDN Terms#

Term, Definition table
TermDefinition
Hand railA device that is fixed to the wall and is of differing bar shaped designs that is intended to provide a person with a disability a supportive hand-hold whilst standing and moving.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
252468293
Device count
1
DM exempt
true
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00689281031875Dependa-Bar, Brushed Stainless SteelDBT-BS031872026-09-22
00689281037372Dependa-Bar, Polished ChromeDBT-CP037372026-09-22
00689281037389Dependa-Bar, Smooth WhiteDBT-SW037382026-09-22
00689281037457PLUS Shampoo Shelf 24 + Grab Bar, Matte BlackPLUS-SHS24-BLK037452026-09-22
00689281037464PLUS Shampoo Shelf 24 + Grab Bar, Brushed StainlessPLUS-SHS24-BS037462026-09-22
00689281037471PLUS Shampoo Shelf 24 + Grab Bar, Chrome PolishedPLUS-SHS24-CP037472026-09-22
00689281039598PLUS Shampoo Shelf 24 + Grab Bar, Oil Rubbed BronzePLUS-SHS24-ORB039592026-09-22
00689281037334"Easy Mount™ Grab Bar, 1.25x12"", Brushed Stainless"GB-12-BS037342026-04-14
00689281010382e2™ Ceiling Mount Trapeze with 24 in. Grab BarSTP-CM-24010382021-08-25
00689281010450e2™ Ceiling Mount Trapeze with 32 in. Grab BarSTP-CM-32010452021-08-25
00689281037204PLUS Crescent Grab Bar, Oil Rubbed BronzePLUS-CGB-ORB037202024-01-29
00689281037228PLUS Corner Shelf + Grab Bar, Oil Rubbed BronzePLUS-CS-ORB 037222024-01-29
00689281037235PLUS Towel Bar + Grab Bar, Oil Rubbed BronzePLUS-TB24-ORB 037232024-01-29
00689281037242PLUS Towel Hook, Oil Rubbed BronzePLUS-TH-ORB037242024-01-29
00689281037259PLUS Towel Ring + Grab Bar, Oil Rubbed BronzePLUS-TR-ORB037252024-01-29
00689281037266PLUS Toilet Paper Holder, Oil Rubbed BronzePLUS-TP-ORB 037262024-01-29
00689281037303"Easy Mount™ Grab Bar, 1.25x12"", Oil Rubbed Bronze"GB-12-ORB 037302024-01-29
00689281037310"Easy Mount™ Grab Bar, 1.25x18"", Oil Rubbed Bronze"GB-18-ORB037312024-01-29
00689281037327"Easy Mount™ Grab Bar, 1.25x24"", Oil Rubbed Bronze"GB-24-ORB037322024-01-29
10689281037201PLUS Crescent Grab Bar, Oil Rubbed BronzePLUS-CGB-ORB037202024-01-29

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