Apex

Primary DI
05391529588489
Brand
Apex
Company
ORTHOXEL DESIGNATED ACTIVITY COMPANY
Model
E04-010
Catalog number
E04-010
Device description
Apex Endcap Tibial/Retrograde 10mm Length
Published
2022-02-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSBRod, Fixation, Intramedullary And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391529588489PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391529588489053915295884895391529588489

GMDN Terms#

Term, Definition table
TermDefinition
Bone nail end-capA small, rounded plug, cover or threaded screw designed to seal the proximal end of an orthopaedic nail implanted to treat a damaged bone (e.g., a fracture), to prevent healing tissue from growing into the hollow nail and to facilitate nail extraction. It is typically made of metal [e.g., high-grade stainless steel, titanium (Ti)], and is available in a variety of sizes. It may also be used to securely lock the most proximal oblique locking screw or help extend the length of a nail when necessary. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00ambient storage and handling

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
646-661-3167CUSTOMERCARE@ORTHOXEL.COM

Regulatory Flags#

DUNS number
985596830
Device count
1
DM exempt
true
Premarket exempt
false
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391529588786ApexINS-1197INS-11972023-07-11
05391529588793ApexINS-1198INS-11982023-07-11
05391543064273ApexINS-1191INS-11912023-07-11
05391529587970ApexF05-100460F05-1004602023-07-10
05391529587987ApexF05-110240F05-1102402023-07-10
05391529587994ApexF05-110260F05-1102602023-07-10
05391529588007ApexF05-110280F05-1102802023-07-10
05391529588014ApexF05-110300F05-1103002023-07-10
05391529588021ApexF05-110320F05-1103202023-07-10
05391529588038ApexF05-110340F05-1103402023-07-10
05391529588045ApexF05-110360F05-1103602023-07-10
05391529588052ApexF05-110380F05-1103802023-07-10
05391529588069ApexF05-110400F05-1104002023-07-10
05391529588076ApexF05-110420F05-1104202023-07-10
05391529588083ApexF05-110440F05-1104402023-07-10
05391529588090ApexF05-110460F05-1104602023-07-10
05391529588106ApexF05-115240F05-1152402023-07-10
05391529588113ApexF05-115260F05-1152602023-07-10
05391529588120ApexF05-115280F05-1152802023-07-10
05391529588137ApexF05-115300F05-1153002023-07-10

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Primary DI, Brand, Company table
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00887868150357Affixus®Zimmer, Inc.HSB2026-03-19
00887868150364Affixus®Zimmer, Inc.HSB2026-03-19
00887868150371Affixus®Zimmer, Inc.HSB2026-03-19
00887868150388Affixus®Zimmer, Inc.HSB2026-03-19
00887868150395Affixus®Zimmer, Inc.HSB2026-03-19
00887868150401Affixus®Zimmer, Inc.HSB2026-03-19
00887868150555Affixus®Zimmer, Inc.HSB2026-03-19
00887868150562Affixus®Zimmer, Inc.HSB2026-03-19
00887868150579Affixus®Zimmer, Inc.HSB2026-03-19
00887868150586Affixus®Zimmer, Inc.HSB2026-03-19
00887868150593Affixus®Zimmer, Inc.HSB2026-03-19
00887868150609Affixus®Zimmer, Inc.HSB2026-03-19
00887868150616Affixus®Zimmer, Inc.HSB2026-03-19
00887868150883Affixus®Zimmer, Inc.HSB2026-03-19
00887868150890Affixus®Zimmer, Inc.HSB2026-03-19
00887868150906Affixus®Zimmer, Inc.HSB2026-03-19
00887868150913Affixus®Zimmer, Inc.HSB2026-03-19
00887868150920Affixus®Zimmer, Inc.HSB2026-03-19
00889024700253Affixus®Zimmer, Inc.HSB2026-03-19
00889024700260Affixus®Zimmer, Inc.HSB2026-03-19
00889024700277Affixus®Zimmer, Inc.HSB2026-03-19
00889024700284Affixus®Zimmer, Inc.HSB2026-03-19
00889024700291Affixus®Zimmer, Inc.HSB2026-03-19
00888867463363Arthrex®ARTHREX, INC.HSB2026-03-16
00888867529069Arthrex®ARTHREX, INC.HSB2026-03-16
00888867529076Arthrex®ARTHREX, INC.HSB2026-03-16
00888867529137Arthrex®ARTHREX, INC.HSB2026-03-16