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4.2mm Dia. Drill, 15mm
Altus Spine, LLC
1030-0240
In Commercial Distribution
- 00843210189369 ()
- Surgical screwdriver, reusable
4.2mm Dia. Drill, 15mm
Altus Spine, LLC
1030-0235
In Commercial Distribution
- 00843210189352 ()
- Surgical screwdriver, reusable
4.2mm Dia. Drill, 15mm
Altus Spine, LLC
1030-0230
In Commercial Distribution
- 00843210189345 ()
- Surgical screwdriver, reusable
4.2mm Dia. Drill, 15mm
Altus Spine, LLC
1030-0225
In Commercial Distribution
- 00843210189338 ()
- Surgical screwdriver, reusable
4.2mm Dia. Drill, 15mm
Altus Spine, LLC
1030-0220
In Commercial Distribution
- 00843210189321 ()
- Surgical screwdriver, reusable
4.2mm Dia. Drill, 15mm
Altus Spine, LLC
1030-0215
In Commercial Distribution
- 00843210189314 ()
- Surgical screwdriver, reusable
The METICULY Patient-specific titanium maxillofacial mesh implant is a device designed individually for each patient and intended for use in selective trauma of the maxillofacial skeleton, maxillofacial surgery, and reconstructive procedures. It is specifically designed with a focus on applications of non-bending related scenarios. The implant is made of titanium alloys produced via additive manufacturing (Laser Powder Bed Fusion) and is intended to be used with titanium screws. All additive manufacturing and other post processing steps are only to take place under Meticuly manufacturing control. The device is not intended to substitute for bone reconstruction in clinical situations where bone is needed for support and stability of the maxillofacial skeleton under functional loading conditions. It is intended for adults only (at least 22 years of age). The surgeon approves the design of the mesh implant prior to fabrication of the implant device by the sponsor. The proposed FaciMesh models are intended to treat the maxillofacial region, while the OrbiMesh models treat the Orbital region. The device is not intended for reconstruction of the orbital roof defects or for any frontal bone defects, such as the supra-orbital ridge. Additionally, the FDA-cleared commercially available titanium screws that can be used with the subject devices include the TITANIUM MINIPLATE SYSTEM (K951690) and MICRO TITANIUM PLATE SYSTEM (K951688).
METICULY COMPANY LIMITED
MF-314
In Commercial Distribution
- 18859751213141 ()
- 08859751213144 ()
- Craniofacial fixation plate, non-bioabsorbable, non-customized
The METICULY Patient-specific titanium maxillofacial mesh implant is a device designed individually for each patient and intended for use in selective trauma of the maxillofacial skeleton, maxillofacial surgery, and reconstructive procedures. It is specifically designed with a focus on applications of non-bending related scenarios. The implant is made of titanium alloys produced via additive manufacturing (Laser Powder Bed Fusion) and is intended to be used with titanium screws. All additive manufacturing and other post processing steps are only to take place under Meticuly manufacturing control. The device is not intended to substitute for bone reconstruction in clinical situations where bone is needed for support and stability of the maxillofacial skeleton under functional loading conditions. It is intended for adults only (at least 22 years of age). The surgeon approves the design of the mesh implant prior to fabrication of the implant device by the sponsor. The proposed FaciMesh models are intended to treat the maxillofacial region, while the OrbiMesh models treat the Orbital region. The device is not intended for reconstruction of the orbital roof defects or for any frontal bone defects, such as the supra-orbital ridge. Additionally, the FDA-cleared commercially available titanium screws that can be used with the subject devices include the TITANIUM MINIPLATE SYSTEM (K951690) and MICRO TITANIUM PLATE SYSTEM (K951688).
METICULY COMPANY LIMITED
MF-313
In Commercial Distribution
- 18859751213134 ()
- 08859751213137 ()
- Craniofacial fixation plate, non-bioabsorbable, non-customized
The METICULY Patient-specific titanium maxillofacial mesh implant is a device designed individually for each patient and intended for use in selective trauma of the maxillofacial skeleton, maxillofacial surgery, and reconstructive procedures. It is specifically designed with a focus on applications of non-bending related scenarios. The implant is made of titanium alloys produced via additive manufacturing (Laser Powder Bed Fusion) and is intended to be used with titanium screws. All additive manufacturing and other post processing steps are only to take place under Meticuly manufacturing control. The device is not intended to substitute for bone reconstruction in clinical situations where bone is needed for support and stability of the maxillofacial skeleton under functional loading conditions. It is intended for adults only (at least 22 years of age). The surgeon approves the design of the mesh implant prior to fabrication of the implant device by the sponsor. The proposed FaciMesh models are intended to treat the maxillofacial region, while the OrbiMesh models treat the Orbital region. The device is not intended for reconstruction of the orbital roof defects or for any frontal bone defects, such as the supra-orbital ridge. Additionally, the FDA-cleared commercially available titanium screws that can be used with the subject devices include the TITANIUM MINIPLATE SYSTEM (K951690) and MICRO TITANIUM PLATE SYSTEM (K951688).
METICULY COMPANY LIMITED
MF-312
In Commercial Distribution
- 18859751213127 ()
- 08859751213120 ()
- Craniofacial fixation plate, non-bioabsorbable, non-customized
The METICULY Patient-specific titanium maxillofacial mesh implant is a device designed individually for each patient and intended for use in selective trauma of the maxillofacial skeleton, maxillofacial surgery, and reconstructive procedures. It is specifically designed with a focus on applications of non-bending related scenarios. The implant is made of titanium alloys produced via additive manufacturing (Laser Powder Bed Fusion) and is intended to be used with titanium screws. All additive manufacturing and other post processing steps are only to take place under Meticuly manufacturing control. The device is not intended to substitute for bone reconstruction in clinical situations where bone is needed for support and stability of the maxillofacial skeleton under functional loading conditions. It is intended for adults only (at least 22 years of age). The surgeon approves the design of the mesh implant prior to fabrication of the implant device by the sponsor. The proposed FaciMesh models are intended to treat the maxillofacial region, while the OrbiMesh models treat the Orbital region. The device is not intended for reconstruction of the orbital roof defects or for any frontal bone defects, such as the supra-orbital ridge. Additionally, the FDA-cleared commercially available titanium screws that can be used with the subject devices include the TITANIUM MINIPLATE SYSTEM (K951690) and MICRO TITANIUM PLATE SYSTEM (K951688).
METICULY COMPANY LIMITED
MF-311
In Commercial Distribution
- 18859751213110 ()
- 08859751213113 ()
- Craniofacial fixation plate, non-bioabsorbable, non-customized
MICROCECT CURETTE, BACKWARD ANGLE, #2
HNM STAINLESS, LLC.
HNM-2-13-1002
In Commercial Distribution
- 00842962162712 ()
HNM-2-13-1002
- Surgical mallet
MICROCECT CURETTE, BACKWARD ANGLE, #1
HNM STAINLESS, LLC.
HNM-2-13-1001
In Commercial Distribution
- 00842962162705 ()
HNM-2-13-1001
- Surgical mallet
KOCHER HEMOSTATIC FORCEPS, 5 5/8", STR
HNM STAINLESS, LLC.
HNM-1-16-1214
In Commercial Distribution
- 00842962162699 ()
HNM-1-16-1214
- Surgical mallet
SUTURE RETRIEVER STRAIGHT, SERRATED WL 6" 155MM
HNM STAINLESS, LLC.
HNM-5-820-300
In Commercial Distribution
- 00842962162682 ()
HNM-5-820-300
- Surgical mallet
HIGH-SIDED PERFORATED TRAY, 8X5X2"
HNM STAINLESS, LLC.
HNM-36-151841
In Commercial Distribution
- 00842962162675 ()
HNM-36-151841
- Surgical mallet
8" KERRISON RONGEUR 4MM
HNM STAINLESS, LLC.
HNM-09-150274
In Commercial Distribution
- 00842962162668 ()
HNM-09-150274
- Surgical mallet
8" KERRISON RONGEUR 4MM
HNM STAINLESS, LLC.
HNM-10-5844
In Commercial Distribution
- 00842962162651 ()
HNM-10-5844
- Surgical mallet
DOANE "Z" KNEE RETRACTOR - LARGE
HNM STAINLESS, LLC.
HNM-1-78-5998
In Commercial Distribution
- 00842962162644 ()
HNM-1-78-5998
- Surgical mallet
MICHEL SUTURE CLIP, 20mm, 1000/PK
HNM STAINLESS, LLC.
HNM-1-13-8020
In Commercial Distribution
- 00842962162637 ()
HNM-1-13-8020
- Surgical mallet
DENNISTON DILATOR, SOFT PLASTIC, DOUBLE ENDED, SET OF 5
HNM STAINLESS, LLC.
HNM-36-150523
Not in Commercial Distribution
- 00842962162620 ()
HNM-36-150523
- Surgical mallet
SMALL CERVICAL DILATOR, 7 1/2", SINGLE ENDED, SET OF 6
HNM STAINLESS, LLC.
HNM-36-150522
In Commercial Distribution
- 00842962162613 ()
HNM-36-150522
- Surgical mallet
MINI DILATOR SET - (5) PROBES (1mm/1.5mm/2mm/2.5mm/3mm) AND (1) HANDLE
HNM STAINLESS, LLC.
HNM-36-151393
In Commercial Distribution
- 00842962162606 ()
HNM-36-151393
- Surgical mallet
SUREFLEX EZ CURETTE, 3.6mm
HNM STAINLESS, LLC.
H-M0016/SGL
Not in Commercial Distribution
- 00842962162590 ()
H-M0016/SGL
- Surgical mallet
MINI INTERFERENCE SCISSOR SCREW DRIVER, 1/4" QUICK CONNECT, LONG
HNM STAINLESS, LLC.
HNM-18-10004-L
In Commercial Distribution
- 00842962161753 ()
HNM-18-10004-L
- Suturing unit, reusable
INTERFERENCE POWER SCISSORS SCREW DRIVER
HNM STAINLESS, LLC.
HNM-18-10003
In Commercial Distribution
- 00842962161678 ()
HNM-18-10003
- Instrument tray, reusable
Dental Implant Surgical Instrument - Driver
Ossvis Co., Ltd.
HLCNRSGF
In Commercial Distribution
- 08809918274006 ()
- Surgical screwdriver, reusable
Dental Implant Surgical Instrument - Driver
Ossvis Co., Ltd.
HNNRLWGF
In Commercial Distribution
- 08809918273993 ()
- Surgical screwdriver, reusable
Dental Implant Surgical Instrument - Driver
Ossvis Co., Ltd.
HNRLWGF
In Commercial Distribution
- 08809918273986 ()
- Surgical screwdriver, reusable
Dental Implant Surgical Instrument - Driver
Ossvis Co., Ltd.
HLCNRSEGF
In Commercial Distribution
- 08809918273979 ()
- Surgical screwdriver, reusable
Dental Implant Surgical Instrument - Driver
Ossvis Co., Ltd.
HNNRLEGF
In Commercial Distribution
- 08809918273962 ()
- Surgical screwdriver, reusable
Dental Implant Surgical Instrument - Driver
Ossvis Co., Ltd.
HNRLEGF
In Commercial Distribution
- 08809918273955 ()
- Surgical screwdriver, reusable
Dental Implant Surgical Instrument - Driver
Ossvis Co., Ltd.
HARSWGF
In Commercial Distribution
- 08809918273948 ()
- Surgical screwdriver, reusable
Dental Implant Surgical Instrument - Driver
Ossvis Co., Ltd.
HLWORSW
In Commercial Distribution
- 08809918273269 ()
- Surgical screwdriver, reusable
Dental Implant Surgical Instrument - Driver
Ossvis Co., Ltd.
HLWORSE
In Commercial Distribution
- 08809918273252 ()
- Surgical screwdriver, reusable
Dental Implant Accessories - Laboratory Driver
Ossvis Co., Ltd.
HOLAH
In Commercial Distribution
- 08809918249998 ()
- Surgical screwdriver, reusable
Dental Implant Surgical Instrument - Driver
Ossvis Co., Ltd.
HLWOSRLW
In Commercial Distribution
- 08809918259973 ()
- Surgical screwdriver, reusable
Dental Implant Surgical Instrument - Driver
Ossvis Co., Ltd.
HORSW
In Commercial Distribution
- 08809918257337 ()
- Surgical screwdriver, reusable
Dental Implant Surgical Instrument - Driver
Ossvis Co., Ltd.
HORSE
In Commercial Distribution
- 08809918257320 ()
- Surgical screwdriver, reusable
Dental Implant Surgical Instrument - Driver
Ossvis Co., Ltd.
HLLFRSE
In Commercial Distribution
- 08809918257313 ()
- Surgical screwdriver, reusable
Dental Implant Surgical Instrument - Driver
Ossvis Co., Ltd.
HLLFRLW
In Commercial Distribution
- 08809918257306 ()
- Surgical screwdriver, reusable