FDA.report

N/A

Primary DI
00614138115484
Brand
N/A
Company
TETRA MEDICAL SUPPLY CORP.
Model
4023P7
Catalog number
4023P7
Device description
FOREARM SPLINT PAD LG/LT
Published
2022-08-04
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
00614138115484PrimaryGS10

GMDN Terms

TermDefinition
Hand/finger splint, reusableA prefabricated (non-customized) wearable rigid or semi-rigid device intended to immobilize an injured/diseased hand and/or finger to support, align or prevent injury during the healing process. It is applied externally to the hand/finger/wrist and typically held in place with self-retaining fasteners (e.g., Velcro bands) or bandage wraps. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
18006214041sales@tetramed.com

Regulatory Flags

DUNS number
047580212
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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

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00614138113459N/A2149-042149-042022-08-19
00614138113466N/A2149-062149-062022-08-19

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