FDA.report

MKO WRIST 10.5" LT MD

Primary DI
00610570161003
Brand
MKO WRIST 10.5" LT MD
Company
Bird & Cronin, LLC
Model
BC 8661-LM
Published
2022-08-20
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

Related Records

Product Codes

CodeName
IQIOrthosis, Limb Brace

Product Code Classifications

CodeDeviceSpecialtyClass
IQIOrthosis, Limb BracePhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00610570161003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00610570161003006105701610036105701610030610570161003

GMDN Terms

TermDefinition
Wrist immobilizer, single-useA rigid support designed to temporarily render the wrist immovable (i.e., prevention of flexion, extension, and rotation) as therapy for non-displaced fractures, strains, sprains, and muscle injuries of the wrist and/or to prevent injury during a procedure (e.g., radial catheterization). The rigid support typically includes a wrap which may be held in place with a fastener such as Velcro; it is available in a variety of sizes. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
045975349
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

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00610570174638ENVELOPE STYLE ARM SLING LG081400642022-08-02
00610570174645ENVELOPE STYLE ARM SLING XL081400652022-08-02

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