FDA.reportPublic FDA data

Resting Hand Splint

Primary DI
00810006682298
Brand
Resting Hand Splint
Company
PRIMO INC
Model
RHS02LM
Catalog number
RHS02LM
Device description
Resting Hand Splint - Medium (Left)
Published
2019-02-27
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
true

Product Codes#

Code, Name table
CodeName
ILHSplint, Hand, And Components

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILHSplint, Hand, And ComponentsPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810006682298PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810006682298008100066822988100066822980810006682298

GMDN Terms#

Term, Definition table
TermDefinition
Hand/finger splint, single-useA non-sterile rigid or semi-rigid device that is used to immobilize an injured hand to protect injuries to, e.g., the digits, metacarpals, and wrist during the healing process. It is applied externally to the hand/finger/wrist and is held in place with, e.g., a bandage or self-retaining Velcro bands. This is a single-patient device that may be reapplied over a short term (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
958758146
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810006683513Economy Foam Heel ProtectorHP301HP3012021-07-26
10810006683520AirFloat Static Air Seat CushionAF1717AF17172021-07-26
10810006683537AirFloat Static Air Seat CushionAF1717PAF1717P2021-07-26
10810006683742Wipe Down Body Wedge Set BPW10FBPW10F2021-07-26
10810006683759Wipe Down Body Wedge Set BPW11FBPW11F2021-07-26
10810006683780Glide & Guide Turn System KitGGTS02GGTS022021-07-26
10810006683797Glide & Guide Turn System KitGGTS02BGGTS02B2021-07-26
10810006683803Glide & Guide Turn System KitGGTS01GGTS012021-07-26
10810006683810Glide & Guide Turn System KitGGTS01BGGTS01B2021-07-26
10810006683827Glide & Guide Turn System Kit EconomyGGTS03GGTS032021-07-26
10810006683834Glide & Guide Turn System Kit EconomyGGTS03BGGTS03B2021-07-26
10810006683841Wipe Down Body Wedge Set, RoundedBPW10RBPW10R2021-07-26
10810006683858Wipe Down Body Wedge Set, RoundedBPW11RBPW11R2021-07-26
10810006684053Glide & Guide Turn System KitGGTS05GGTS052021-07-26
10810006684060Glide & Guide Turn System KitGGTS05BGGTS05B2021-07-26
10810006684077Glide & Guide Turn System KitGGTS06BGGTS06B2021-07-26
10810006684084Glide & Guide Turn System KitGGTS06GGTS062021-07-26
10810006684091Glide & Guide Turn System Kit EconomyGGTS04GGTS042021-07-26
10810006684107Glide & Guide Turn System Kit EconomyGGTS04BGGTS04B2021-07-26
10810006684114AirFloat Static Air Seat CushionAF1919PAF1919P2021-07-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810220800041Adler Instrument CompanyAdler, Inc.ILH2026-03-17
00817355025806KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-12
00817355025820KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-12
00817355025868KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-12
00817355026247KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-12
00810178883943ViveVIVE HEALTH LLCILH2026-03-06
00817355021976KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355025790KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355025813KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355025837KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355025844KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355025899KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355025912KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355025967KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355025974KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355025981KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355026018KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355026025KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355026032KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355026056KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355026230KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355026292KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355026360KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355026698KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355026711KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355026735KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355026896KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355026902KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355022805KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-05
00817355026667KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-05