FDA.report

Plastalume

Primary DI
00082161121237
Brand
Plastalume
Company
BROWNMED, INC.
Model
12123
Device description
Classic Forearm 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
00082161121237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00082161121237000821611212370821611212370082161121237

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

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00649833103047Polar IceA103042020-08-12
00649833103054Polar IceA103052020-08-12
00649833103061Polar IceA10306T2020-08-12
00656480507111JoslinJ007112020-09-09
00656480507128JoslinJ007122020-09-09

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