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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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UL_INJECT - 04052536002245

XD 8000, ulrichINJECT CT motion composed of:
Ulrich GmbH & Co. KG
XD 8000
In Commercial Distribution

  • 04052536002245 ()
XD 8000

  • CT contrast medium injection system, line-powered, mobile

NA - 10886982236401

4.0MM/3.0MM TI SLF-DRLG SCHANZ SCREW 80MM/HA COATING-STERILE
Synthes GmbH
494.771SHA
In Commercial Distribution

  • H679494771SHA0 ()
  • 10886982236401 ()
494771SHA

  • External orthopaedic fixation system, reusable

Fixone Biocomposite Anchor - 08806109701068

The Fixone Biocomposite Anchor is intended for reattaching soft tissue to bone with sutures. The anchor ismanufactured from biodegradable materials (PLGA copolymer and beta-TCP). A nonabsorbable UHMWPE suture is inserted into the anchor. The anchor is implanted using a provided driver. B,N,BN type(Knotted suture anchors) are ‘screw-in’ anchors used alone or in combination with Kc,KcN type(Knotless suture anchors) for soft-tissue repair. Kc,KcN type(Knotless suture anchor) are used for a soft-tissue repair in combination with the B,N,BN type. SL type ‘push-in’ anchors that are ideal for soft-tissue repair in narrow or deep areas. S type are ‘push-in’ anchors that are ideal for soft-tissue repair in the foot, ankle, hand and wrist The Fixone Biocomposite Anchor consists of cannulated anchors with an eyelet. They are pre-loaded on an insertion device. The Fixone Biocomposite Anchor is intended to provide secure reattachment of the soft tissue to bone. Devices are provided sterile. Single use only.
AJU PHARM. CO., LTD.
SAB-30002e
In Commercial Distribution

  • 08806109701068 ()


  • Tendon/ligament bone anchor, bioabsorbable

Align - 00841506102092

No Description
SKELETAL DYNAMICS L.L.C.
Driver Extraction Tool
In Commercial Distribution

  • 00841506102092 ()
HNDL-UQC-DXT

  • Elbow radius prosthesis

Geminus - 00841506101552

No Description
SKELETAL DYNAMICS L.L.C.
Initial Driver, Polyaxial Locking Screw
In Commercial Distribution

  • 00841506101552 ()
GMN-ID-PLS

  • Orthopaedic implant driver

Align - 00841506101347

No Description
SKELETAL DYNAMICS L.L.C.
Driver, Universal QC, T-20
In Commercial Distribution

  • 00841506101347 ()
DRVR-UQC-T20

  • Elbow radius prosthesis

IMPlate - 00841506101323

No Description
SKELETAL DYNAMICS L.L.C.
Driver, Mini QC T-7
In Commercial Distribution

  • 00841506101323 ()
DRVR-MQC-T07

  • Surgical screwdriver, single-use

REDUCT® Headless Compression Screw - 00841506101316

No Description
SKELETAL DYNAMICS L.L.C.
HCS Driver, 3.5mm
In Commercial Distribution

  • 00841506101316 ()
DRVR-HCS-1420

  • Surgical screwdriver, single-use

REDUCT® Headless Compression Screw - 00841506101309

No Description
SKELETAL DYNAMICS L.L.C.
HCS Driver, 2.5mm
In Commercial Distribution

  • 00841506101309 ()
DRVR-HCS-0915

  • Surgical screwdriver, single-use

Geminus - 00841506101286

No Description
SKELETAL DYNAMICS L.L.C.
Driver, AO Connection, Polyaxial Locking Screw
In Commercial Distribution

  • 00841506101286 ()
DRVR-AOS-PLS

  • Surgical screwdriver, single-use
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