Anjon Bremer Halo System SPA1

GUDID 10810592030470

Anjon Bremer Halo System Torque Limit Knobs, 8/pk

ANJON HOLDINGS LLC

Orthopaedic bone pin, non-bioabsorbable
Primary Device ID10810592030470
NIH Device Record Keydcbcf8a4-541f-4f91-a0a3-f9057adceb6d
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnjon Bremer Halo System
Version Model NumberTorque Limit Knobs, 8/pk
Catalog NumberSPA1
Company DUNS080902221
Company NameANJON HOLDINGS LLC
Device Count8
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-877-430-8690
Emailinfo@generixmedical.com
Phone1-877-430-8690
Emailinfo@generixmedical.com
Phone1-877-430-8690
Emailinfo@generixmedical.com
Phone1-877-430-8690
Emailinfo@generixmedical.com
Phone1-877-430-8690
Emailinfo@generixmedical.com
Phone1-877-430-8690
Emailinfo@generixmedical.com
Phone1-877-430-8690
Emailinfo@generixmedical.com
Phone1-877-430-8690
Emailinfo@generixmedical.com
Phone1-877-430-8690
Emailinfo@generixmedical.com
Phone1-877-430-8690
Emailinfo@generixmedical.com
Phone1-877-430-8690
Emailinfo@generixmedical.com
Phone1-877-430-8690
Emailinfo@generixmedical.com
Phone1-877-430-8690
Emailinfo@generixmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810592030251 [Unit of Use]
GS110810592030470 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JECComponent, Traction, Invasive

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2023-09-18
Device Publish Date2018-04-20

On-Brand Devices [Anjon Bremer Halo System]

00810592030534Anjon Bremer Halo System Traction Set Clamps
00810592030442Anjon Bremer Halo System Torque Pin Driver
00810592030435Anjon Bremer Halo System Head Positioning Spoon
00810592030428Anjon Bremer Halo System Light Vest, Shoulder Strap
00810592030411Anjon Bremer Halo System Light Vest, Waist Strap, Tall
00810592030404Anjon Bremer Halo System Light Vest, Waist Strap, Short
00810592030398Anjon Bremer Halo System Classic Vest, Waist Strap, 15in (39cm)
00810592030381Anjon Bremer Halo System Transverse Bar, 9 inch
00810592030374Anjon Bremer Halo System Traction Bale
00810592030367Anjon Bremer Halo System Pediatric Vest Liner Replacement, Child
00810592030350Anjon Bremer Halo System Positioning Pins and Pads, 3/pk
00810592030343Anjon Bremer Halo System Pediatric Vest Liner Replacement, Toddler
00810592030329Anjon Bremer Halo System Liner Replacement Material
00810592030312Anjon Bremer Halo System Light Vest, Waist Strap, Gray
00810592030305Anjon Bremer Halo System Light Vest Liner Replacement, Tall
00810592030299Anjon Bremer Halo System Light Vest Liner Replacement, Short
00810592030275Anjon Bremer Halo System Classic Vest, Waist Strap, 22in (56cm)
00810592030268Anjon Bremer Halo System Black Aluminum Wrench, 5 inch
00810592030244Anjon Bremer Halo System Pediatric Vest, Child 22-28 in. (56-72cm)
00810592030237Anjon Bremer Halo System Pediatric Vest, Toddler 20-24 in. (50-62cm)
00810592030220Anjon Bremer Halo System Pediatric Ring, Large 17-19 1/2 in. (43-50cm)
00810592030213Anjon Bremer Halo System Pediatric Ring, Small 15-16 in. (38-40cm)
00810592030206Anjon Bremer Halo System Crown, Large 23-26 in (58-66cm)
00810592030190Anjon Bremer Halo System Crown, Small 19-23 in (48-58cm)
00810592030176Anjon Bremer Halo System Classic Vest, Xlarge 42-58 in. (108-148cm)
00810592030169"Anjon Bremer Halo System Classic Vest, Large (176cm and taller) 36-42 in. (92-108cm)"
00810592030152Anjon Bremer Halo System Classic Vest, Small (176cm and shorter) 32-38 in. (82-98cm)
00810592030145Anjon Bremer Halo System Classic Vest, Petite/Slim (160cm and shorter) 26-34 in. (66-86cm)
00810592030138Anjon Bremer Halo System Classic Vest Liner Replacement, Xlarge
00810592030121Anjon Bremer Halo System Classic Vest Liner Replacement, Large
00810592030114Anjon Bremer Halo System Classic Vest Liner Replacement, Small
00810592030107Anjon Bremer Halo System Classic Vest Liner Replacement, Petite/Slim
00810592030077Anjon Bremer Halo System Light Vest, Kyphosis
00810592030060Anjon Bremer Halo System Light Vest, Tall (170cm and taller) 30-44 in. (76-112cm)
00810592030053Anjon Bremer Halo System Light Vest, Short (170cm and shorter) 28-38 in. (72-98cm)
00810592030046Anjon Bremer Halo System Adjustable Ring , Size C 21-26 in (56-66cm)
00810592030039Anjon Bremer Halo System Adjustable Ring, Size B 19-23 in (48-58cm)
00810592030008Anjon Bremer Halo System Torque Pin Driver, Disposable
20810592030521Anjon Bremer Halo System Torque Limit Knobs, Red, 28/pk
20810592030491Anjon Bremer Halo System Skull Pin Accessory Pack, Standard 59mm, 10/pk
00810592030633Anjon Bremer Halo System Molded Halo Crown - Sterile
00810592030763Anjon Bremer Halo System, Mayfield Adaptor Set Ant/Post - Non Sterile
00810592030756Anjon Bremer Halo System, Extra Long Halo Skull Pins 2 Non-Sterile
00810592030749Anjon Bremer Halo System, Standard Halo Skull Pins 5 Non-Sterile
00810592030695Anjon Bremer Halo System, Cutting Tip Halo Skull Pins 5 Non-Sterile
00810592030688Anjon Bremer Halo System, Molded Crown Non-Sterile
00810592030671Anjon Bremer Halo System, Titanium Torque Driver set
00810592030664Anjon Bremer Halo System, Large Adjustable Ring Sterile
00810592030657Anjon Bremer Halo System, Small Pediatric Ring Sterile
00810592030640Anjon Bremer Halo System, Large Pediatric Ring Sterile
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