FDA.reportPublic FDA data

Plastalume

Primary DI
00082161106265
Brand
Plastalume
Company
BROWNMED, INC.
Model
10626
Device description
Strips
Published
2020-08-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
FYHSplint, Extremity, Noninflatable, External, Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYHSplint, Extremity, Noninflatable, External, SterileGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00082161106265PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00082161106265000821611062650821611062650082161106265

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
091999771
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00082161600008IMAK RSI600002020-08-26
00082161600107IMAK RSI600102020-08-26
00082161600206IMAK RSI600202020-08-26
00082161605003IMAK RSI605002020-08-26
00649833101128IMAK RSIA101122020-08-26
00649833103122IMAK RSIA103122020-08-26
00649833201309IMAK CompressionA201302020-08-26
00649833201316IMAK CompressionA201312020-08-26
00649833201323IMAK CompressionA201322020-08-26
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00026072012208SCAllied Medical, LLCFYH2024-05-09
00026072022771SCAllied Medical, LLCFYH2024-05-09
00026072022788SCAllied Medical, LLCFYH2024-05-09
00026072022795SCAllied Medical, LLCFYH2024-05-09
00026072022801SCAllied Medical, LLCFYH2024-05-09
00026072022818SCAllied Medical, LLCFYH2024-05-09
00026072022825SCAllied Medical, LLCFYH2024-05-09
00026072022894SCAllied Medical, LLCFYH2024-05-09
00026072022900SCAllied Medical, LLCFYH2024-05-09
00817612020964Dale Post Surgical BraDale Medical Products, Inc.FYH2024-04-25
00861887000213INRO Surgical NailInro Medical Designs IncFYH2023-08-17
10861887000210INRO Surgical NailInro Medical Designs IncFYH2023-08-17
00817612020995Dale Strapless Bendable ArmboardDALE MEDICAL PRODUCTS, INC.FYH2020-09-14
00817612021015Dale Strapless Bendable ArmboardDALE MEDICAL PRODUCTS, INC.FYH2020-09-14
00082161503118Nice StretchBROWNMED, INC.FYH2020-08-17
00082161503125Nice StretchBROWNMED, INC.FYH2020-08-17
00082161503200Nice StretchBROWNMED, INC.FYH2020-08-17
00082161510000Nice StretchBROWNMED, INC.FYH2020-08-17
00082161510017Nice StretchBROWNMED, INC.FYH2020-08-17
00082161510024Nice StretchBROWNMED, INC.FYH2020-08-17
00082161510031Nice StretchBROWNMED, INC.FYH2020-08-17
00082161510208Nice StretchBROWNMED, INC.FYH2020-08-17
00082161510215Nice StretchBROWNMED, INC.FYH2020-08-17
00082161510222Nice StretchBROWNMED, INC.FYH2020-08-17
00082161510239Nice StretchBROWNMED, INC.FYH2020-08-17
00082161510307Nice StretchBROWNMED, INC.FYH2020-08-17
00082161510314Nice StretchBROWNMED, INC.FYH2020-08-17
00082161510321Nice StretchBROWNMED, INC.FYH2020-08-17
00082161510338Nice StretchBROWNMED, INC.FYH2020-08-17
00082161520603Nice StretchBROWNMED, INC.FYH2020-08-17