FDA.reportPublic FDA data

Anjon Bremer Halo System

Primary DI
00810592030640
Brand
Anjon Bremer Halo System
Company
ANJON HOLDINGS LLC
Model
Large Pediatric Ring Sterile
Catalog number
100047
Device description
Anjon Bremer Halo System, Large Pediatric Ring Sterile
Published
2020-04-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JECComponent, Traction, Invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JECComponent, Traction, InvasiveOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810592030647PackageGS13In Commercial Distribution
00810592030640PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081059203064710810592030647
00810592030640008105920306408105920306400810592030640

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone pin, non-bioabsorbableA small diameter rod typically used for the fixation of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. The rod may be smooth, wholly- or partially-threaded, solid or cannulated, and some designs may be tapered; it is not specific to the clavicle bone. The device is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). Some designs may have a break-off shank and/or may be coated [e.g., with hydroxyapatite, also known as hydroxylapatite (HA)] to improve purchase in osteoporotic bone and for long-term fixation. This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-877-430-8690info@anjonholdings.com

Regulatory Flags#

DUNS number
080902221
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810592030289Anjon Bremer Halo SystemRing Set Accessory PackARA12018-04-20
10810592030333Anjon Bremer Halo SystemPediatric Ring Set Accessory PackPRA12018-04-20
10810592030456Anjon Bremer Halo SystemCrown Set Accessory PackHCA12018-04-20
10810592030463Anjon Bremer Halo SystemSkull Pin Accessory Pack, Standard 59mm, 10/pkP4102018-04-20
10810592030470Anjon Bremer Halo SystemTorque Limit Knobs, 8/pkSPA12018-04-20
10810592030487Anjon Bremer Halo SystemTorque Limit Knobs, 4/pkLPA12018-04-20
10810592030500Anjon Bremer Halo SystemSkull Pin, Standard 59mm, 5/pkP452018-04-20
10810592030517Anjon Bremer Halo SystemSkull Pin, Long 71mm, 2/pkP522018-04-20
00810592030701Anjon Bremer Halo System7/16 OPEN END WRENCH2020-05-21
00810592030497Anjon Bremer Halo SystemPediatric Halo Skull Pins 10 Non-Sterile1000172020-04-01
00810592030558Anjon Bremer Halo SystemSmall Adjustable Ring Sterile1000562020-04-01
00810592030565Anjon Bremer Halo SystemLarge Halo Crown Sterile1000552020-04-01
00810592030572Anjon Bremer Halo SystemSmall Halo Crown Sterile1000542020-04-01
00810592030589Anjon Bremer Halo SystemMayfield Adaptor Set Ant/Post - Molded Crown1000532020-04-01
00810592030596Anjon Bremer Halo SystemCutting Tip Halo Skull Pins 5 Sterile1000522020-04-01
00810592030602Anjon Bremer Halo SystemExtra Long Halo Skull Pins 2 Sterile1000512020-04-01
00810592030619Anjon Bremer Halo SystemStandard Halo Skull Pins 5 Sterile1000502020-04-01
00810592030626Anjon Bremer Halo SystemPediatric Halo Skull Pins 10 Sterile1000492020-04-01
00810592030657Anjon Bremer Halo SystemSmall Pediatric Ring Sterile1000462020-04-01
00810592030664Anjon Bremer Halo SystemLarge Adjustable Ring Sterile 1000452020-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10888277680500MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-29
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10888277680531MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-29
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10888277680562MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-29
10888277680579MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-29