FDA.reportPublic FDA data

N/A

Primary DI
00889024369283
Brand
N/A
Company
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
Model
00-1231-005-00
Catalog number
00-1231-005-00
Device description
BRADY SPLINT ASSEMBLY
Published
2020-12-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IOZSplint, Abduction, Congenital Hip Dislocation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IOZSplint, Abduction, Congenital Hip DislocationPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024369283PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024369283008890243692838890243692830889024369283

GMDN Terms#

Term, Definition table
TermDefinition
External orthopaedic fixation system, reusableAn assembly of devices designed to stabilize fractured bones, other than those in the vertebral column, to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, cams, bushings, collars, bolts and nuts; it may also include some instrumentation (e.g., screw drivers, wrenches, drills). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the wrist, elbow, knee, hip and ankle, joint fusions, and limb lengthening. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-2759zimmer.consumerrelations@zimmerbiomet.com

Regulatory Flags#

DUNS number
137354267
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024686120Oxford Surgical BladesOXF3PKXHUBOXF3PKXHUB2026-05-21
00889024686151Oxford Surgical BladesOXF3PKAES3OXF3PKAES32026-05-21
00889024686175Oxford Surgical BladesOXFKLSYKOXFKLSYK2026-05-21
00889024686083Oxford Surgical BladesOXF3PKLINVPOXF3PKLINVP2026-05-20
00889024686090Oxford Surgical BladesOXF3PKLINVVOXF3PKLINVV2026-05-20
00889024686106Oxford Surgical BladesOXF3PKSYKOXF3PKSYK2026-05-20
00889024686113Oxford Surgical BladesOXF3PKSYNOXF3PKSYN2026-05-20
00889024686137Oxford Surgical BladesOXF3PKZIMUOXF3PKZIMU2026-05-20
00889024686144Oxford Surgical BladesOXF3PKDESMOXF3PKDESM2026-05-20
00889024686168Oxford Surgical BladesOXFKLLINOXFKLLIN2026-05-20
00889024686182Oxford Surgical BladesOXFKLSYNOXFKLSYN2026-05-20
00889024686199Oxford Surgical BladesOXFKLZIMBOXFKLZIMB2026-05-20
00889024686205Oxford Surgical BladesOXFKLAESCOXFKLAESC2026-05-20
00889024375901Dermatome00-8801-001-0000-8801-001-002021-03-03
00889024464834Dermatome88710100887101002017-01-26
00889024626447A.T.S.® Personalized Pressure®60320010100603200101002023-08-30
00889024626454A.T.S.® Personalized Pressure®60-5000-101-00605000101002022-03-30
00889024375024PULSAVAC®00-5150-350-0000-5150-350-002016-08-12
00889024375031PULSAVAC®00-5150-350-0100-5150-350-012016-08-12
00889024375048PULSAVAC®00-5150-350-0200-5150-350-022016-08-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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H93350840110Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IOZ2023-06-08
H93350840120Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IOZ2023-06-08
H93350840210Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IOZ2023-06-08
H93350840245Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IOZ2023-06-08
H93350840250Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IOZ2023-06-08
H93300267100100Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IOZ2023-06-07
H93300267100200Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IOZ2023-06-07
H93300267100300Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IOZ2023-06-07
H93300267500000Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IOZ2023-06-07
00645517327983TrulifeTRULIFE LIMITEDIOZ2022-12-31
00645517327990TrulifeTRULIFE LIMITEDIOZ2022-12-31
00645517328003TrulifeTRULIFE LIMITEDIOZ2022-12-31
G088DSHKOR0PanaceaBlake Manufacturing, Inc.IOZ2022-09-06
G088DSHKOS0PanaceaBlake Manufacturing, Inc.IOZ2022-09-06
G088HKOR0BMIBlake Manufacturing, Inc.IOZ2022-08-15
G088HKOS0BMIBlake Manufacturing, Inc.IOZ2022-08-15
00749756018029DeRoyalDEROYAL INDUSTRIES, INC.IOZ2021-07-29
00749756018036DeRoyalDEROYAL INDUSTRIES, INC.IOZ2021-07-29
00749756018043DeRoyalDEROYAL INDUSTRIES, INC.IOZ2021-07-29
00889024369207N/AZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.IOZ2020-12-15
00889024369214N/AZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.IOZ2020-12-15
00889024369221N/AZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.IOZ2020-12-15
00696588003580Slimline™ Abduction Pillow Innovative Medical Products, IncIOZ2020-06-02
00696588003597Slimline™ Abduction Pillow Innovative Medical Products, IncIOZ2020-06-02
00696588003795Pediatric Abduction PillowInnovative Medical Products, IncIOZ2020-06-02
00696588003818Universal Abduction PillowInnovative Medical Products, IncIOZ2020-06-02
00696588005447Slimline™ Abduction Pillow Innovative Medical Products, IncIOZ2020-06-02
00696588005485Pediatric Abduction PillowInnovative Medical Products, IncIOZ2020-06-02
00696588006116Universal Abduction PillowInnovative Medical Products, IncIOZ2020-06-02