FDA.report

Plastalume

Primary DI
00082161125136
Brand
Plastalume
Company
BROWNMED, INC.
Model
12513
Device description
Palm Metacarpal Splint
Published
2020-08-13
Public version status
New
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
ILHSplint, Hand, And Components

Product Code Classifications

CodeDeviceSpecialtyClass
ILHSplint, Hand, And ComponentsPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00082161125136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00082161125136000821611251360821611251360082161125136

GMDN Terms

TermDefinition
Hand/finger splint, reusableA 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., self-retaining Velcro bands. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
091999771
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
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00082161300113Polar Ice300112020-08-12
00082161300120Polar Ice300122020-08-12
00082161300137Polar Ice300132020-08-12
00082161300144Polar Ice300142020-08-12
00082161300366Polar Ice300362020-08-12
00082161301004Polar Ice301002020-08-12
00082161301011Polar Ice301012020-08-12
00082161301028Polar Ice301022020-08-12
00082161301035Polar Ice301032020-08-12
00082161301042Polar Ice301042020-08-12
00082161301059Polar Ice301052020-08-12
00082161301073Polar Ice301072020-08-12
00082161301080Polar Ice301082020-08-12
00082161301097Polar Ice301092020-08-12
00649833103030Polar IceA103032020-08-12
00649833103047Polar IceA103042020-08-12
00649833103054Polar IceA103052020-08-12
00649833103061Polar IceA10306T2020-08-12
00656480507111JoslinJ007112020-09-09
00656480507128JoslinJ007122020-09-09

Other Devices Sharing Product Codes

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