No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00810019931994 | LRG-601 | Lumbar Rod Gripper with Box Ratchet | LXH | Orthopedic Manual Surgical Instrument | 1 | Bradshaw Medical | |
2 | 00810019931529 | HRC212312 | HRC601 | Handheld Ratcheting Rod Cutter,3.2mm, 3.5mm Silpad BlackSold as OEM | HXZ | Cutter, Wire | 1 | Bradshaw Medical |
3 | 00810019931253 | 925-0601 | 925-0601 | BIT, PHILLIPS® #1 1/4 SQ | HXX | Screwdriver | 1 | Bradshaw Medical Inc. |
4 | 00810019931246 | 925-0503 | 925-0503 | BIT, BLADE LARGE .05" X .25" 1/4 SQ | HXX | Screwdriver | 1 | Bradshaw Medical Inc. |
5 | 00810019931307 | 925-0903 | 925-0903 | BIT, INT.SCREW REMOVER 6.0MM 1/4 SQ | HXX | Screwdriver | 1 | Bradshaw Medical Inc. |
6 | 00810019931352 | 925-1003 | 925-1003 | BIT, EXT. SCREW REMOVER 3.5MM 1/4 SQ | HXX | Screwdriver | 1 | Bradshaw Medical Inc. |
7 | 00810019931239 | 925-0502 | 925-0502 | BIT, BLADE MEDIUM .04" X .22" 1/4 SQ | HXX | Screwdriver | 1 | Bradshaw Medical Inc. |
8 | 00810019931390 | RIV-30-11-03C | RIV-30-11-03C | Large Ratchet, Palm Handle, 1/4" Square Internal Adapter, Ø.188 Cannulation.Sil Large Ratchet, Palm Handle, 1/4" Square Internal Adapter, Ø.188 Cannulation.Silicone Color code "C"Sold as OEM | HXX | Screwdriver | 1 | Bradshaw Medical Inc. |
9 | 00810019931383 | 925-1102 | 925-1102 | BIT, SADDLE 6.0MM 1/4 SQ. | HXX | Screwdriver | 1 | Bradshaw Medical Inc. |
10 | 00810019931376 | 925-1101 | 925-1101 | BIT, SADDLE 5.0MM 1/4 SQ | HXX | Screwdriver | 1 | Bradshaw Medical Inc. |
11 | 00810019931369 | 925-1004 | 925-1004 | BIT, EXT. SCREW REMOVER 4.0MM 1/4 SQ | HXX | Screwdriver | 1 | Bradshaw Medical Inc. |
12 | 00810019930607 | RIV-15-11-01DG-ATEC | RIV-15-11-01DG-ATEC | LARGE RATCHET, EXTREME AXIAL HANDLE, 1/4 SQUARE INTERNAL ADAPTER | HXX | Screwdriver | 1 | Bradshaw Medical Inc. |
13 | 00810019931345 | 925-1002 | 925-1002 | BIT, EXT. SCREW REMOVER 3.0MM 1/4 SQ | HXX | Screwdriver | 1 | Bradshaw Medical Inc. |
14 | 00810019931338 | 925-1001 | 925-1001 | BIT, EXT. SCREW REMOVER 2.5MM 1/4 SQ. | HXX | Screwdriver | 1 | Bradshaw Medical Inc. |
15 | 00810019931321 | 925-0905 | 925-0905 | BIT, INT.SCREW REMOVER 8.0MM 1/4 SQ | HXX | Screwdriver | 1 | Bradshaw Medical Inc. |
16 | 00810019931314 | 925-0904 | 925-0904 | BIT, INT.SCREW REMOVER 7.0MM 1/4 SQ | HXX | Screwdriver | 1 | Bradshaw Medical Inc. |
17 | 00810019931291 | 925-0902 | 925-0902 | BIT, INT.SCREW REMOVER 5.0MM 1/4 SQ | HXX | Screwdriver | 1 | Bradshaw Medical Inc. |
18 | 00810019931284 | 925-0901 | 925-0901 | BIT, INT.SCREW REMOVER 4.0MM 1/4 SQ | HXX | Screwdriver | 1 | Bradshaw Medical Inc. |
19 | 00810019931277 | 925-0802 | 925-0802 | BIT, CRUCIFORM 6.0MM 1/4 SQ | HXX | Screwdriver | 1 | Bradshaw Medical Inc. |
20 | 00810019931260 | 925-0801 | 925-0801 | BIT, CRUCIFORM 5.0MM 1/4 SQ | HXX | Screwdriver | 1 | Bradshaw Medical Inc. |
21 | 00810019931222 | 925-0501 | 925-0501 | BIT, BLADE SMALL .04" X .19" 1/4 SQ | HXX | Screwdriver | 1 | Bradshaw Medical Inc. |
22 | 00810019931215 | 925-0405 | 925-0405 | BIT, TREPHINE 8.0MM 1/4 SQ | HWK | Trephine | 1 | Bradshaw Medical Inc. |
23 | 00810019931208 | 925-0404 | 925-0404 | BIT, TREPHINE 7.0MM 1/4 SQ | HWK | Trephine | 1 | Bradshaw Medical Inc. |
24 | 00810019931192 | 925-0403 | 925-0403 | BIT, TREPHINE 6.0MM 1/4 SQ | HWK | Trephine | 1 | Bradshaw Medical Inc. |
25 | 00810019931185 | 925-0402 | 925-0402 | BIT, TREPHINE 5.0MM 1/4 SQ | HWK | Trephine | 1 | Bradshaw Medical Inc. |
26 | 00810019931161 | 925-0304 | 925-0304 | BIT, HEXALOBE 30 1/4 SQ | HXX | Screwdriver | 1 | Bradshaw Medical Inc. |
27 | 00810019931154 | 925-0305 | 925-0305 | BIT, HEXALOBE 27 1/4 SQ | HXX | Screwdriver | 1 | Bradshaw Medical Inc. |
28 | 00810019931147 | 925-0303 | 925-0303 | BIT, HEXALOBE 25 1/4 SQ | HXX | Screwdriver | 1 | Bradshaw Medical Inc. |
29 | 00810019931130 | 925-0302 | 925-0302 | BIT, HEXALOBE 20 1/4 SQ | HXX | Screwdriver | 1 | Bradshaw Medical Inc. |
30 | 00810019931123 | 925-0301 | 925-0301 | BIT, HEXALOBE 15 1/4 SQ | HXX | Screwdriver | 1 | Bradshaw Medical Inc. |
31 | 00810019931116 | 925-0327 | 925-037 | BIT, HEXALOBE 12 1/4 SQ | HXX | Screwdriver | 1 | Bradshaw Medical Inc. |
32 | 00810019931109 | 925-0326 | 925-0326 | BIT, HEXALOBE 10 1/4 SQ | HXX | Screwdriver | 1 | Bradshaw Medical Inc. |
33 | 00810019931093 | 925-0215 | 925-0215 | BIT, HEX FEMALE 1/2 1/4 SQ | HXX | Screwdriver | 1 | Bradshaw Medical Inc. |
34 | 00810019931086 | 925-0214 | 925-0214 | BIT, HEX FEMALE 7/16 1/4 SQ | HXX | Screwdriver | 1 | Bradshaw Medical Inc. |
35 | 00810019931079 | 925-0213 | 925-0213 | BIT, HEX FEMALE 3/8 1/4 SQ | HXX | Screwdriver | 1 | Bradshaw Medical Inc. |
36 | 00810019931062 | 925-0212 | 925-0212 | BIT, HEX FEMALE 5/16 1/4 SQ | HXX | Screwdriver | 1 | Bradshaw Medical Inc. |
37 | 00810019931055 | 925-0211 | 925-0211 | BIT, HEX FEMALE 1/4 1/4 SQ | HXX | Screwdriver | 1 | Bradshaw Medical Inc. |
38 | 00810019931048 | 925-0210 | 925-0210 | BIT, HEX FEMALE 7/32 1/4 SQ | HXX | Screwdriver | 1 | Bradshaw Medical Inc. |
39 | 00810019931031 | 925-0209 | 925-0209 | BIT, HEX FEMALE 3/16 1/4 SQ | HXX | Screwdriver | 1 | Bradshaw Medical Inc. |
40 | 00810019931024 | 925-0208 | 925-0208 | BIT, HEX FEMALE 5/32 1/4 SQ | HXX | Screwdriver | 1 | Bradshaw Medical Inc. |
41 | 00810019931017 | 925-0207 | 925-0207 | BIT, HEX FEMALE 1/8 1/4 SQ | HXX | Screwdriver | 1 | Bradshaw Medical Inc. |
42 | 00810019931000 | 925-0206 | 925-0206 | BIT, HEX FEMALE 10MM 1/4 SQ | HXX | Screwdriver | 1 | Bradshaw Medical Inc. |
43 | 00810019930997 | 925-0205 | 925-0205 | BIT, HEX FEMALE 9.0MM 1/4 SQ | HXX | Screwdriver | 1 | Bradshaw Medical Inc. |
44 | 00810019930980 | 925-0204 | 925-0204 | BIT, HEX FEMALE 8.0MM 1/4 SQ | HXX | Screwdriver | 1 | Bradshaw Medical Inc. |
45 | 00810019930973 | 925-0203 | 925-0203 | BIT, HEX FEMALE 7.0MM 1/4 SQ | HXX | Screwdriver | 1 | Bradshaw Medical Inc. |
46 | 00810019930966 | 925-0202 | 925-0202 | BIT, HEX FEMALE 6.0MM 1/4 SQ | HXX | Screwdriver | 1 | Bradshaw Medical Inc. |
47 | 00810019930959 | 925-0201 | 925-0201 | BIT, HEX FEMALE 5.0MM 1/4 SQ | HXX | Screwdriver | 1 | Bradshaw Medical Inc. |
48 | 00810019930942 | 925-0116 | 925-0116 | BIT, HEX MALE 1/4 1/4 SQ | HXX | Screwdriver | 1 | Bradshaw Medical Inc. |
49 | 00810019930935 | 925-0115 | 925-0115 | BIT, HEX MALE 7/32 1/4 SQ | HXX | Screwdriver | 1 | Bradshaw Medical Inc. |
50 | 00810019930928 | 925-0114 | 925-0114 | BIT, HEX MALE 3/16 1/4 SQ | HXX | Screwdriver | 1 | Bradshaw Medical Inc. |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00841036149901 | 01-0954 | 01-0954 | N/A | BIOMET MICROFIXATION, INC | |
2 | 00841036008574 | 01-0950 | 01-0950 | N/A | BIOMET MICROFIXATION, INC | |
3 | 00840180507179 | CI-10866 | Iliac Crest Graft Punch | General Instrument | ALPHATEC SPINE, INC. | |
4 | 00840105220015 | Z-6527 | Mucotomy Bur 5.0mm | ZOLL-DENTAL | ZOLL-DENTAL | |
5 | 00840105220008 | Z-6526 | Mucotomy Bur 4.0mm | ZOLL-DENTAL | ZOLL-DENTAL | |
6 | 00840105219996 | Z-6525 | Mucotomy Bur 3.5mm | ZOLL-DENTAL | ZOLL-DENTAL | |
7 | 00840105219989 | Z-6524 | Trephine Bur 9.5mm | ZOLL-DENTAL | ZOLL-DENTAL | |
8 | 00840105219972 | Z-6523 | Trephine Bur 7.5mm | ZOLL-DENTAL | ZOLL-DENTAL | |
9 | 00840105219965 | Z-6522 | Trephine Bur 4.5mm | ZOLL-DENTAL | ZOLL-DENTAL | |
10 | 00840105219958 | Z-6521 | Trephine Bur 2.5mm | ZOLL-DENTAL | ZOLL-DENTAL | |
11 | 00840105219941 | Z-6520 | Trephine Bur 6.5mm | ZOLL-DENTAL | ZOLL-DENTAL | |
12 | 00840105219934 | Z-6519 | Trephine Bur 5.5mm | ZOLL-DENTAL | ZOLL-DENTAL | |
13 | 00840105219927 | Z-6518 | Trephine Bur 4.0mm | ZOLL-DENTAL | ZOLL-DENTAL | |
14 | 00840105219910 | Z-6517 | Trephine Bur 10.0mm | ZOLL-DENTAL | ZOLL-DENTAL | |
15 | 00840105219903 | Z-6516 | Trephine Bur 9.0mm | ZOLL-DENTAL | ZOLL-DENTAL | |
16 | 00840105219897 | Z-6515 | Trephine Bur 8.5mm | ZOLL-DENTAL | ZOLL-DENTAL | |
17 | 00840105219880 | Z-6514 | Trephine Bur 8.0mm | ZOLL-DENTAL | ZOLL-DENTAL | |
18 | 00840105219873 | Z-6513 | Trephine Bur 7.0mm | ZOLL-DENTAL | ZOLL-DENTAL | |
19 | 00840105219866 | Z-6512 | Trephine Bur 6.0mm | ZOLL-DENTAL | ZOLL-DENTAL | |
20 | 00840105219859 | Z-6511 | Trephine Bur 5.0mm | ZOLL-DENTAL | ZOLL-DENTAL | |
21 | 00840105219842 | Z-6510 | Trephine Bur 3.5mm | ZOLL-DENTAL | ZOLL-DENTAL | |
22 | 00840105219835 | Z-6509 | Trephine Bur 3.0mm | ZOLL-DENTAL | ZOLL-DENTAL | |
23 | 00840105219828 | Z-6508 | Trephine Bur 2.0mm | ZOLL-DENTAL | ZOLL-DENTAL | |
24 | 00812337021265 | 58160-20 | Single-use disposable orthopedic manual surgical instrument set | ProChondrix® Instrument Set | DSM BIOMEDICAL, INC. | |
25 | 00812337021258 | 58160-17 | Single-use disposable orthopedic manual surgical instrument set | ProChondrix® Instrument Set | DSM BIOMEDICAL, INC. | |
26 | 00812337021241 | 58160-15 | Single-use disposable orthopedic manual surgical instrument set | ProChondrix® Instrument Set | DSM BIOMEDICAL, INC. | |
27 | 00812337021234 | 58160-13 | Single-use disposable orthopedic manual surgical instrument set | ProChondrix® Instrument Set | DSM BIOMEDICAL, INC. | |
28 | 00812337021227 | 58160-11 | Single-use disposable orthopedic manual surgical instrument set | ProChondrix® Instrument Set | DSM BIOMEDICAL, INC. | |
29 | 00812337021210 | 58160-09 | Single-use disposable orthopedic manual surgical instrument set | ProChondrix® Instrument Set | DSM BIOMEDICAL, INC. | |
30 | 00812337021203 | 58160-07 | Single-use disposable orthopedic manual surgical instrument sets | ProChondrix® Instrument Set | DSM BIOMEDICAL, INC. | |
31 | 00811954012694 | 6008 | 6008 | https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=523872# | 2.7mm Trephine Removal | INTERVENTIONAL SPINE, INC |
32 | 00810019931215 | 925-0405 | 925-0405 | BIT, TREPHINE 8.0MM 1/4 SQ | Bradshaw Medical Inc. | BRADSHAW MEDICAL, INC. |
33 | 00810019931208 | 925-0404 | 925-0404 | BIT, TREPHINE 7.0MM 1/4 SQ | Bradshaw Medical Inc. | BRADSHAW MEDICAL, INC. |
34 | 00810019931192 | 925-0403 | 925-0403 | BIT, TREPHINE 6.0MM 1/4 SQ | Bradshaw Medical Inc. | BRADSHAW MEDICAL, INC. |
35 | 00810019931185 | 925-0402 | 925-0402 | BIT, TREPHINE 5.0MM 1/4 SQ | Bradshaw Medical Inc. | BRADSHAW MEDICAL, INC. |
36 | 00810019931178 | 925-0401 | 925-0401 | BIT, TREPHINE 4.0MM 1/4 SQ | Bradshaw Medical Inc. | BRADSHAW MEDICAL, INC. |
37 | 00810019930331 | 920-0408 | 920-0408 | BIT, TREPHINE 7.0MM AO | Bradshaw Medical Inc. | BRADSHAW MEDICAL, INC. |
38 | 00810019930324 | 920-0407 | 920-0407 | BIT, TREPHINE 6.0MM AO | Bradshaw Medical Inc. | BRADSHAW MEDICAL, INC. |
39 | 00810019930317 | 920-0406 | 920-0406 | BIT, TREPHINE 5.0MM AO | Bradshaw Medical Inc. | BRADSHAW MEDICAL, INC. |
40 | 00810019930300 | 920-0405 | 920-0405 | BIT, TREPHINE 4.5MM AO | Bradshaw Medical Inc. | BRADSHAW MEDICAL, INC. |
41 | 00810019930294 | 920-0404 | 920-0404 | BIT, TREPHINE 4.0MM AO | Bradshaw Medical Inc. | BRADSHAW MEDICAL, INC. |
42 | 00810019930287 | 920-0403 | 920-0403 | BIT, TREPHINE 3.5MM AO | Bradshaw Medical Inc. | BRADSHAW MEDICAL, INC. |
43 | 00810019930270 | 920-0402 | 920-0402 | BIT, TREPHINE 3.0MM AO | Bradshaw Medical Inc. | BRADSHAW MEDICAL, INC. |
44 | 00810019930263 | 920-0401 | 920-0401 | BIT, TREPHINE 2.5MM AO | Bradshaw Medical Inc. | BRADSHAW MEDICAL, INC. |
45 | 00763000078942 | EX0817013 | TREPHINE EX0817013 | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | |
46 | 00721902949388 | Y8087780 | 8.0MM BONE SCREW TREPHINE | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | |
47 | 00721902949371 | Y8087775 | 7.5MM BONE SCREW TREPHINE | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | |
48 | 00721902949364 | Y8087770 | 7.0MM BONE SCREW TREPHINE | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | |
49 | 00721902949340 | Y8087760 | 6.0MM BONE SCREW TREPHINE | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | |
50 | 00721902949333 | Y8087755 | 5.5MM BONE SCREW TREPHINE | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. |