No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | M711CRT006ST0 | CRT006ST | CP Ti | GWO | Plate, Cranioplasty, Preformed, Alterable | 2 | Neuro & Craniofacial Fixation System | |
2 | M711E20024 | E2002 | E2002 | KWQ,KWP,MNH,MNI,NKB | Appliance, Fixation, Spinal Intervertebral Body,Appliance, Fixation, Spinal Inte Appliance, Fixation, Spinal Intervertebral Body,Appliance, Fixation, Spinal Interlaminal,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation,Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease | Excella II® | ||
3 | M711BTA1190 | BTA-119 | Al, SST, Nylon, Silicone | LXH | Orthopedic Manual Surgical Instrument | 1 | PSO | |
4 | M711X212163200 | X21216320 | X21216320 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
5 | M711X212163000 | X21216300 | X21216300 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
6 | M711X212162800 | X21216280 | X21216280 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
7 | M711X212153200 | X21215320 | X21215320 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
8 | M711X212153000 | X21215300 | X21215300 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
9 | M711X212152800 | X21215280 | X21215280 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
10 | M711X212143200 | X21214320 | X21214320 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
11 | M711X212143000 | X21214300 | X21214300 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
12 | M711X212142800 | X21214280 | X21214280 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
13 | M711X212133200 | X21213320 | X21213320 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
14 | M711X212133000 | X21213300 | X21213300 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
15 | M711X212132800 | X21213280 | X21213280 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
16 | M711X212123200 | X21212320 | X21212320 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
17 | M711X212123000 | X21212300 | X21212300 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
18 | M711X212122800 | X21212280 | X21212280 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
19 | M711X212113200 | X21211320 | X21211320 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
20 | M711X212113000 | X21211300 | X21211300 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
21 | M711X212112800 | X21211280 | X21211280 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
22 | M711X212103200 | X21210320 | X21210320 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
23 | M711X212103000 | X21210300 | X21210300 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
24 | M711X212102800 | X21210280 | X21210280 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
25 | M711X212093200 | X21209320 | X21209320 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
26 | M711X212093000 | X21209300 | X21209300 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
27 | M711X212092800 | X21209280 | X21209280 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
28 | M711X212082800 | X21208280 | X21208280 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
29 | M711X210162550 | X21016255 | X21016255 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
30 | M711X210162500 | X21016250 | X21016250 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
31 | M711X210162250 | X21016225 | X21016225 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
32 | M711X210162200 | X21016220 | X21016220 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
33 | M711X210153200 | X21015320 | X21015320 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
34 | M711X210152800 | X21015280 | X21015280 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
35 | M711X210152550 | X21015255 | X21015255 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
36 | M711X210152500 | X21015250 | X21015250 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
37 | M711X210152250 | X21015225 | X21015225 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
38 | M711X210152200 | X21015220 | X21015220 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
39 | M711X210143200 | X21014320 | X21014320 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
40 | M711X210142800 | X21014280 | X21014280 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
41 | M711X210142550 | X21014255 | X21014255 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
42 | M711X210142500 | X21014250 | X21014250 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
43 | M711X210142250 | X21014225 | X21014225 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
44 | M711X210142200 | X21014220 | X21014220 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
45 | M711X210133200 | X21013320 | X21013320 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
46 | M711X210132800 | X21013280 | X21013280 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
47 | M711X210132550 | X21013255 | X21013255 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
48 | M711X210132500 | X21013250 | X21013250 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
49 | M711X210132250 | X21013225 | X21013225 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
50 | M711X210132200 | X21013220 | X21013220 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | B089B630150 | B63015 | B63015 | TEBBETTS RONGEUR; 6 1/4''(16CM) , 2.5MM JAW | N/A | BLACK & BLACK SURGICAL, INC. |
2 | B089B630100 | B63010 | B63010 | BEYER STAINLESS STEEL RONGEUR; 7''(18CM), 3MM JAW | N/A | BLACK & BLACK SURGICAL, INC. |
3 | B089B522180 | B52218 | B52218 | GORNEY ONYX MORSELIZERS; GUARD ONLY | N/A | BLACK & BLACK SURGICAL, INC. |
4 | B089B522170 | B52217 | B52217 | GORNEY ONYX MORSELIZERS; 8.0''(20CM), STRAIGHT | N/A | BLACK & BLACK SURGICAL, INC. |
5 | B089B522150 | B52215 | B52215 | GORNEY ONYX MORSELIZERS; 8''(20CM), ANGLED | N/A | BLACK & BLACK SURGICAL, INC. |
6 | B089B522130 | B52213 | B52213 | BERNSTEIN FORCEPS; SEPTAL, ARCHED, CARBIDE JAW, 8 1/4" (21CM) | N/A | BLACK & BLACK SURGICAL, INC. |
7 | B089B522110 | B52211 | B52211 | GUNTER ONYX MORSELIZERS; 7"(18CM), LONGITUDINAL JAW | N/A | BLACK & BLACK SURGICAL, INC. |
8 | B089B522100 | B52210 | B52210 | GUNTER ONYX MORSELIZERS; 7"(18CM) | N/A | BLACK & BLACK SURGICAL, INC. |
9 | B07319K0861500 | 19-K08-6150 | 19-K08-6150 | Pituitary, Up Biting, 3mm | Kalitec Disc Prep | KALITEC DIRECT LLC |
10 | B07319K0861400 | 19-K08-6140 | 19-K08-6140 | Pituitary, Straight, 3mm | Kalitec Disc Prep | KALITEC DIRECT LLC |
11 | B06217607081 | 1760-7081 | 1760-7081 | 8mm Sypert Rongeur, 335mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
12 | B06217607080 | 1760-7080 | 1760-7080 | 5mm Sypert Rongeur, 335mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
13 | B06217607079 | 1760-7079 | 1760-7079 | 6mm Pituitary Rongeur, Angled Down, Bayonetted, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
14 | B06217607078 | 1760-7078 | 1760-7078 | 6mm Pituitary Rongeur, Angled Up, Bayonetted, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
15 | B06217607077 | 1760-7077 | 1760-7077 | 6mm Pituitary Rongeur, Bayonetted, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
16 | B06217607076 | 1760-7076 | 1760-7076 | 6mm Pituitary Rongeur, Angled Down, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
17 | B06217607075 | 1760-7075 | 1760-7075 | 6mm Pituitary Rongeur, Angled Up, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
18 | B06217607074 | 1760-7074 | 1760-7074 | 6mm Pituitary Rongeur, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
19 | B06217607073 | 1760-7073 | 1760-7073 | 6mm Kerrison Rongeur, Angled, Bayonetted, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
20 | B06217607072 | 1760-7072 | 1760-7072 | 6mm Kerrison Rongeur, Bayonetted, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
21 | B06217607071 | 1760-7071 | 1760-7071 | 6mm Kerrison Rongeur, Angled, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
22 | B06217607070 | 1760-7070 | 1760-7070 | 6mm Kerrison Rongeur, 350mmhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml# | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
23 | B06217607069 | 1760-7069 | 1760-7069 | 5mm Pituitary Rongeur, Angled Down, Bayonetted, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
24 | B06217607067 | 1760-7067 | 1760-7067 | 5mm Pituitary Rongeur, Bayonetted, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
25 | B06217607066 | 1760-7066 | 1760-7066 | 5mm Pituitary Rongeur, Angled Down, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
26 | B06217607065 | 1760-7065 | 1760-7065 | 5mm Pituitary Rongeur, Angled Up, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
27 | B06217607064 | 1760-7064 | 1760-7064 | 5mm Pituitary Rongeur, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
28 | B06217607063 | 1760-7063 | 1760-7063 | 5mm Kerrison Rongeur, Angled, Bayonetted, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
29 | B06217607062 | 1760-7062 | 1760-7062 | 5mm Kerrison Rongeur, Bayonetted, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
30 | B06217607061 | 1760-7061 | 1760-7061 | 5mm Kerrison Rongeur, Angled, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
31 | B06217607060 | 1760-7060 | 1760-7060 | 5mm Kerrison Rongeur, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
32 | B06217607059 | 1760-7059 | 1760-7059 | 4mm Pituitary Rongeur, Angled Down, Bayonetted, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
33 | B06217607058 | 1760-7058 | 1760-7058 | 4mm Pituitary Rongeur, Angled Up, Bayonetted, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
34 | B06217607057 | 1760-7057 | 1760-7057 | 4mm Pituitary Rongeur, Bayonetted, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
35 | B06217607056 | 1760-7056 | 1760-7056 | 4mm Pituitary Rongeur, Angled Down, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
36 | B06217607055 | 1760-7055 | 1760-7055 | 4mm Pituitary Rongeur, Angled Up, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
37 | B06217607054 | 1760-7054 | 1760-7054 | 4mm Pituitary Rongeur, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
38 | B06217607053 | 1760-7053 | 1760-7053 | 4mm Kerrison Rongeur, Angled, Bayonetted, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
39 | B06217607052 | 1760-7052 | 1760-7052 | 4mm Kerrison Rongeur, Bayonetted, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
40 | B06217607051 | 1760-7051 | 1760-7051 | 4mm Kerrison Rongeur, Angled, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
41 | B06217607050 | 1760-7050 | 1760-7050 | 4mm Kerrison Rongeur, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
42 | B06217607049 | 1760-7049 | 1760-7049 | 3mm Pituitary Rongeur, Angled Down, Bayonetted, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
43 | B06217607048 | 1760-7048 | 1760-7048 | 3mm Pituitary Rongeur, Angled Up, Bayonetted, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
44 | B06217607047 | 1760-7047 | 1760-7047 | 3mm Pituitary Rongeur, Bayonetted, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
45 | B06217607046 | 1760-7046 | 1760-7046 | 3mm Pituitary Rongeur, Angled Down, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
46 | B06217607045 | 1760-7045 | 1760-7045 | 3mm Ptuitary Rongeur, Angled Up, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
47 | B06217607044 | 1760-7044 | 1760-7044 | 3mm Ptuitary Rongeur, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
48 | B06217607043 | 1760-7043 | 1760-7043 | 3mm Kerrison Rongeur, Angled, Bayonetted, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
49 | B06217607042 | 1760-7042 | 1760-7042 | 3mm Kerrison Rongeur, Bayonetted, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
50 | B06217607041 | 1760-7041 | 1760-7041 | 3mm Kerrison Rongeur, Angled, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |