MAXFRAME

Primary DI
10886982338778
Brand
MAXFRAME
Company
SYNTHES (U.S.A.) LP
Model
1100022-01
Catalog number
110002201
Device description
MAXFRAME AUTOSTRUT(TM) AUTOMATED HEXAPOD ACCESSORIES
Published
2024-02-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OSNSoftware for diagnosis/treatment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OSNSoftware For Diagnosis/TreatmentOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886982338778PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698233877810886982338778

GMDN Terms#

Term, Definition table
TermDefinition
External orthopaedic fixation system, single-useAn assembly of devices designed to stabilize fractured bones 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, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-30 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
832637081
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H981PDL432FNAPDL432PDL4322017-02-20
H981PDL434HNAPDL434PDL4342017-02-20
07611819995796NA03.820.144038201442016-12-31
07611819943490NAE5115-7E511572017-02-20
H679E51157P09NAE5115-7PE51157P2016-12-31
10886982293060NA04.045.260040452602025-01-31
10886982293237NA04.045.230040452302025-01-31
10886982293244NA04.045.232040452322025-01-31
10886982293251NA04.045.234040452342025-01-31
10886982293268NA04.045.236040452362025-01-31
10886982293275NA04.045.238040452382025-01-31
10886982293282NA04.045.240040452402025-01-31
10886982293299NA04.045.242040452422025-01-31
10886982293305NA04.045.244040452442025-01-31
10886982293312NA04.045.246040452462025-01-31
10886982293329NA04.045.248040452482025-01-31
10886982293336NA04.045.250040452502025-01-31
10886982293343NA04.045.252040452522025-01-31
10886982293350NA04.045.254040452542025-01-31
10886982293367NA04.045.256040452562025-01-31

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Primary DI, Brand, Company table
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00888867516588Arthrex®ARTHREX, INC.OSN2026-03-13
00888867516595Arthrex®ARTHREX, INC.OSN2026-03-13
00888867516618Arthrex®ARTHREX, INC.OSN2026-03-13
00888867543164Arthrex®ARTHREX, INC.OSN2026-03-13
00888867543171Arthrex®ARTHREX, INC.OSN2026-03-13
00888867543195Arthrex®ARTHREX, INC.OSN2026-03-13
00888867543263Arthrex®ARTHREX, INC.OSN2026-03-13
00888867543614Arthrex®ARTHREX, INC.OSN2026-03-13
00888867543720Arthrex®ARTHREX, INC.OSN2026-03-13
00888867543737Arthrex®ARTHREX, INC.OSN2026-03-13
00888867543744Arthrex®ARTHREX, INC.OSN2026-03-13
00888867543751Arthrex®ARTHREX, INC.OSN2026-03-13
00888867543768Arthrex®ARTHREX, INC.OSN2026-03-13
00888867543775Arthrex®ARTHREX, INC.OSN2026-03-13
00888867543782Arthrex®ARTHREX, INC.OSN2026-03-13
00888867543805Arthrex®ARTHREX, INC.OSN2026-03-13
00888867543836Arthrex®ARTHREX, INC.OSN2026-03-13
00888867543867Arthrex®ARTHREX, INC.OSN2026-03-13
00888867544574Arthrex®ARTHREX, INC.OSN2026-03-13
10886982346889MAXFRAMESynthes GmbHOSN2025-04-23
10886982346896MAXFRAMESynthes GmbHOSN2024-12-09
00840194428002Orthex External Fixation SystemORTHOPEDIATRICS CORP.OSN2023-03-03
00885556807071Acute QC Strut and ComponentsSmith & Nephew, Inc.OSN2022-09-07
00885556807088Acute QC Strut and ComponentsSmith & Nephew, Inc.OSN2022-09-07
20885556807112Acute QC Strut and ComponentsSmith & Nephew, Inc.OSN2022-09-07
20885556807129Acute QC Strut and ComponentsSmith & Nephew, Inc.OSN2022-09-07
00885556807064Acute QC Strut and ComponentsSmith & Nephew, Inc.OSN2022-09-06
10886982338570MAXFRAMESYNTHES (U.S.A.) LPOSN2022-04-26