FDA.reportPublic FDA data

Intranasal splint, non-biodegradable

Definition
A non-biodegradable device intended to be temporarily placed via a nostril into the nasal cavity after surgery or trauma to help minimize bleeding by tamponade effect, prevent adhesions between the mucosal surfaces, and provide support to the surrounding tissues during the healing period. It is typically made of plastic, silicone, and/or a blood/liquid absorptive material and is removed at the discretion of the physician. This is a single-use device.
GUDID devices
230
Last updated
2020-10-29 09:29:52

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
05056100706675NETCELLNETWORK MEDICAL PRODUCTS LIMITED35-9502020-10-21
10385640000205Doyle Spacer SplintSummit Medical, Inc.SP-810002020-10-21
00681490041782Goode Magne-Splint™MEDTRONIC XOMED, INC.15160002020-10-12
00858439001620NexPakHEMOSTASIS, LLC91105242020-09-30
00858439001644NexPak XHEMOSTASIS, LLC91105342020-09-30
00860003136409SPIWaySPIWAY LLCSP0042020-08-04
00860003136416SPIWaySPIWAY LLCSP0052020-08-04
20763000040042N/AMEDTRONIC XOMED, INC.15230002020-06-29
20763000040691BOOMERANG®MEDTRONIC XOMED, INC.6005002020-06-29
00763000035631Goode Magne-Splint™MEDTRONIC XOMED, INC.15160002020-04-19
EBES602010Nasal Airway SplintBoston Medical Products, Inc.60-2012015-09-20
EBES602020Doyle Combo SplintBoston Medical Products, Inc.60-2022015-09-20
EBES602030Doyle Open-Lumen SplintBoston Medical Products, Inc.60-2032015-09-20
EBES602040Intranasl Splint INSBoston Medical Products, Inc.60-2042015-09-20
EBES60204L0Intranasl Splint INSBoston Medical Products, Inc.60-204L2015-09-20
EBES603010Bivalve Nasal Splint, StandardBoston Medical Products, Inc.60-3012015-09-20
EBES603020Bivalve Nasal Splint, StandardBoston Medical Products, Inc.60-3022015-09-20
EBES603030Bivalve Nasal Splint, LargeBoston Medical Products, Inc.60-3032015-09-20
EBES603040Bivalve Nasal Splint, LargeBoston Medical Products, Inc.60-3042015-09-20
EBES603101Custom Nasal SplintBOSTON MEDICAL PRODUCTS, INC.60-3102015-09-20
EBES603111Custom Nasal SplintBOSTON MEDICAL PRODUCTS, INC.60-3112015-09-20
EBES603120Custom Nasal SplintBoston Medical Products, Inc.60-3122015-09-20
EBES603131Custom Nasal SplintBOSTON MEDICAL PRODUCTS, INC.60-3132015-09-20
EBES603141Custom Nasal SplintBOSTON MEDICAL PRODUCTS, INC.60-3142015-09-20
EBES603151Custom Nasal SplintBOSTON MEDICAL PRODUCTS, INC.60-3152015-09-20
EBESEP10015251RHINOCELL® Epistaxis PackingBOSTON MEDICAL PRODUCTS, INC.EP-10015252015-09-20
EBESEP5515251RHINOCELL® Epistaxis PackingBOSTON MEDICAL PRODUCTS, INC.EP-5515252015-09-20
EBESNP4515201RHINOCELL® Nasal PackingBOSTON MEDICAL PRODUCTS, INC.NP-4515202015-09-20
EBESNP8015201RHINOCELL® Nasal PackingBOSTON MEDICAL PRODUCTS, INC.NP-8015202015-09-20
EBESNP801520A1RHINOCELL® Nasal PackingBOSTON MEDICAL PRODUCTS, INC.NP-801520A2015-09-20
EBESNP8015301RHINOCELL® Nasal PackingBOSTON MEDICAL PRODUCTS, INC.NP-8015302015-09-20
EBESNP801530A1RHINOCELL® Nasal PackingBOSTON MEDICAL PRODUCTS, INC.NP-801530A2015-09-20
EBESSP3506120RHINOCELL® Sinus PackingBoston Medical Products, Inc.SP-3506122015-09-20
EBESSP3509120RHINOCELL® Sinus PackingBoston Medical Products, Inc.SP-3509122015-09-20
EBESTP4510201RHINOCELL® Nasal PackingBOSTON MEDICAL PRODUCTS, INC.TP-4510202015-09-20
EBESTP8010201RHINOCELL® Nasal PackingBOSTON MEDICAL PRODUCTS, INC.TP-8010202015-09-20
EBESTP8010301RHINOCELL® Nasal PackingBOSTON MEDICAL PRODUCTS, INC.TP-8010302015-09-20
00821925022119SILICONE SEPTAL NASAL SPLINT, STANDARD 1 - LEFT, 1 - RIGHTGyrus Acmi, Inc.8909142018-09-13
00821925022126NASAL SPLINT SMALL 1 - LEFT, 1 - RIGHT SILICONE SEPTALGyrus Acmi, Inc.8909152018-09-13
00821925022133BIVALVE SPLINT, STANDARD THIN. SHORT-TERM USE UP TO 14 DAYS .25MM UHMGyrus Acmi, Inc.8909162018-09-13
00821925022188CUSTOM NASAL SPLINT, THICK SHORT - TERM USE UP TO 14 DAYS .50MM UHMWPGyrus Acmi, Inc.8909212018-09-13
00821925030503WIDELINE NASAL PACK, LARGE (polyvinyl alcohol sponge)Gyrus Acmi, Inc.708907302018-09-13
00821925029965Blu K-Style Sinus Pack' 3.5 cm x .9 cm x 1.2 cm, BacteriostaticGyrus Acmi, Inc.7089-08442018-09-13
00821925029989Blu B-Style Sinus Pack, 2.5 cm x .9 cm x 2.0 cm, BacteriostaticGyrus Acmi, Inc.7089-08462018-09-13
00821925030008Blu T-Style Sinus Pack, 4.5 cm x .9 cm x 2.0 cm, BacteriostaticGyrus Acmi, Inc.7089-08482018-09-13
00821925030022Blu K-Style Sinus Pack, Slim, 3.5 cm x .6 cm x 1.2 cm, BacteriostaticGyrus Acmi, Inc.7089-08502018-09-13
00821925030046Blu B-Style Sinus Pack, Slim, 2.5 cm x .6 cm x 2.0 cm, BacteriostaticGyrus Acmi, Inc.7089-08522018-09-13
008219250300537089-0857 Blu Epistaxis Pack, Small, 5.5 cm x 1.5Gyrus Acmi, Inc.7089-08572018-09-13
00821925030145Blu T-Style Sinus Pack, Slim, 4.5 cm x .6 cm x 2.0Gyrus Acmi, Inc.7089-08542018-09-13
00821925030176Blu Nasal Pack, Small, with Airway, 4.5 cm x 1.5 cm x 2.0 cm, BacteriGyrus Acmi, Inc.7089-08342018-09-13
00821925030190Blu Nasal Pack, Large, with Airway, 8.0 cm x 1.5 cm x 2.0 cm, BacteriGyrus Acmi, Inc.7089-08362018-09-13
00821925030213Blu D-Style Anatomical Nasal Pack, 8.0 cm x 1.5 cm x 3.0 cm, BacterioGyrus Acmi, Inc.7089-08382018-09-13
00821925030237Blu D-Style Anatomical Nasal Pack, with Airway, 8.0 cm x 1.5 cm x 3.0Gyrus Acmi, Inc.7089-08402018-09-13
00821925030671Blu Nasal Pack, Small, 4.5 cm x 1.5 cm x 2.0 cm, BacteriostaticGyrus Acmi, Inc.7089-08302018-09-13
00821925030695Blu Nasal Pack, Large, 8.0 cm x 1.5 cm x 2.0 cm, BacteriostaticGyrus Acmi, Inc.7089-08322018-09-13
00821925017252NEIMAN SEPTAL SPLINT SILICONEGyrus Acmi, Inc.1404412018-09-11
00821925030251Blu D-Style Anatomical Nasal Pack, Slim, 8.0 cm x .75 cm x 3.0 cm, BaGyrus Acmi, Inc.7089-08422018-09-13
00821925029958Blu Glide D-Style Anatomical Nasal Pack, Slim, 8.0 cm x .75 cm x 3.0Gyrus Acmi, Inc.7089-08432018-09-13
00821925029972Blu Glide K-Style Sinus Pack, 3.5 cm x .9 cm x 1.2 cm, BacteriostaticGyrus Acmi, Inc.7089-08452018-09-13
00821925029996Blu Glide B-Style Sinus Pack, 2.5 cm x .9 cm x 2.0 cm, BacteriostaticGyrus Acmi, Inc.7089-08472018-09-13
00821925030015Blu Glide T-Style Sinus Pack, 4.5 cm x .9 cm x 2.0 cm, BacteriostaticGyrus Acmi, Inc.7089-08492018-09-13
00821925030039Blu Glide K-Style Sinus Pack, Slim, 3.5 cm x .6 cm x 1.2 cm, BacterioGyrus Acmi, Inc.7089-08512018-09-13
00821925030138Blu Glide B-Style Sinus Pack, Slim, 2.5 cm x .6 cm x 2.0 cm, BacterioGyrus Acmi, Inc.7089-08532018-09-13
00821925030152Blu Glide T-Style Sinus Pack, Slim, 4.5 cm x .6 cmGyrus Acmi, Inc.7089-08552018-09-13
00821925030169Blu Glide Nasal Pack, Large, 8.0 cm x 1.5 cm x 2.0 cm, BacteriostaticGyrus Acmi, Inc.7089-08332018-09-13
00821925030183Blu Glide Nasal Pack, Small, with Airway, 4.5 cm x 1.5 cm x 2.0 cm BaGyrus Acmi, Inc.7089-08352018-09-13
00821925030206Blu Glide Nasal Pack, Large, with Airway, 8.0 cm x 1.5 cm x 2.0 cm BaGyrus Acmi, Inc.7089-08372018-09-13
00821925030220Blu Glide D-Style Anatomical Nasal Pack, 8.0 cm x 1.5 cm x 3.0 cm BaGyrus Acmi, Inc.7089-08392018-09-13
00821925030244Blu Glide D-Style Anatomical Nasal Pack, with Airway, 8.0 cm x 1.5 cGyrus Acmi, Inc.7089-08412018-09-13
00821925030299RHNO ROCKET SLIMLINE NASAL PACK, SMALL (polyvinyl alcohol sponge)Gyrus Acmi, Inc.708907502018-09-13
00821925030305RHNO ROCKET SLIMLINE NASAL PACK, MEDIUM (polyvinyl alcohol sponge)Gyrus Acmi, Inc.708907512018-09-13
00821925030312RHNO ROCKET SLIMLINE NASAL PACK, LARGE (polyvinyl alcohol sponge)Gyrus Acmi, Inc.708907522018-09-13
00821925030329RHNO ROCKET SLIMLINE NASAL PACK, X-LARGE (polyvinyl alcohol sponge)Gyrus Acmi, Inc.708907532018-09-13
00821925030336RHNO ROCKET WIDELINE NASAL PACK, SMALL (polyvinyl alcohol sponge)Gyrus Acmi, Inc.708907542018-09-13
00821925030343RHNO ROCKET WIDELINE NASAL PACK, MEDIUM (polyvinyl alcohol sponge)Gyrus Acmi, Inc.708907552018-09-13
00821925030350RHNO ROCKET WIDELINE NASAL PACK, LARGE (polyvinyl alcohol sponge)Gyrus Acmi, Inc.708907562018-09-13
00821925030367RHNO ROCKET WIDELINE NASAL PACK, X-LARGE (polyvinyl alcohol sponge)Gyrus Acmi, Inc.708907572018-09-13
00821925030374SLIMLINE NASAL PACK, MEDIUM (polyvinyl alcohol sponge)Gyrus Acmi, Inc.708907332018-09-13
00821925030381SLIMLINE NASAL PACK, LARGE (polyvinyl alcohol sponge)Gyrus Acmi, Inc.708907342018-09-13
00821925030398SLIMLINE NASAL PACK, X-LARGE (polyvinyl alcohol sponge)Gyrus Acmi, Inc.708907352018-09-13