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"Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold a
temporary hemi- shoulder replacement for skeletally mature patients undergoing a two-stage
revision procedure due to a septic process.
The temporary prosthesis is molded using low viscosity polymethylmethacrylate bone
cement and inserted into the humeral medullary canal and glenoid cavity of the shoulder
following removal of the existing humeral and glenoideal cavity implants and debridement.
SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement.
The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy
(standard treatment approach to an infection).
The hemi-shoulder prosthesis made from the SpaceFlex Shoulder disposable cement molds is
not intended for use more than 180 days, at which time it must be explanted and permanent
devices implanted or another appropriate treatment performed (e.g. resection arthroplasty,
fusion, etc.).
Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (low
viscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicated
for patients who will consistently follow activity limitation throughout the implant period.
The device can exclusively be used by competent healthcare personnel who has complete
scientific and anatomical knowledge."
G21 SRL
900001 144818
In Commercial Distribution
- 08058964726087 ()
- Orthopaedic cement spacer mould
Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold a
temporary hemi- shoulder replacement for skeletally mature patients undergoing a two-stage
revision procedure due to a septic process.
The temporary prosthesis is molded using low viscosity polymethylmethacrylate bone
cement and inserted into the humeral medullary canal and glenoid cavity of the shoulder
following removal of the existing humeral and glenoideal cavity implants and debridement.
SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement.
The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy
(standard treatment approach to an infection).
The hemi-shoulder prosthesis made from the SpaceFlex Shoulder disposable cement molds is
not intended for use more than 180 days, at which time it must be explanted and permanent
devices implanted or another appropriate treatment performed (e.g. resection arthroplasty,
fusion, etc.).
Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (low
viscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicated
for patients who will consistently follow activity limitation throughout the implant period.
The device can exclusively be used by competent healthcare personnel who has complete
scientific and anatomical knowledge.
G21 SRL
900001 124818
In Commercial Distribution
- 08058964726070 ()
- Orthopaedic cement spacer mould
Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold a
temporary hemi- shoulder replacement for skeletally mature patients undergoing a two-stage
revision procedure due to a septic process.
The temporary prosthesis is molded using low viscosity polymethylmethacrylate bone
cement and inserted into the humeral medullary canal and glenoid cavity of the shoulder
following removal of the existing humeral and glenoideal cavity implants and debridement.
SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement.
The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy
(standard treatment approach to an infection).
The hemi-shoulder prosthesis made from the SpaceFlex Shoulder disposable cement molds is
not intended for use more than 180 days, at which time it must be explanted and permanent
devices implanted or another appropriate treatment performed (e.g. resection arthroplasty,
fusion, etc.).
Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (low
viscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicated
for patients who will consistently follow activity limitation throughout the implant period.
The device can exclusively be used by competent healthcare personnel who has complete
scientific and anatomical knowledge.
G21 SRL
900001 124215
In Commercial Distribution
- 08058964726063 ()
- Orthopaedic cement spacer mould
Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold a
temporary hemi- shoulder replacement for skeletally mature patients undergoing a two-stage
revision procedure due to a septic process.
The temporary prosthesis is molded using low viscosity polymethylmethacrylate bone
cement and inserted into the humeral medullary canal and glenoid cavity of the shoulder
following removal of the existing humeral and glenoideal cavity implants and debridement.
SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement.
The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy
(standard treatment approach to an infection).
The hemi-shoulder prosthesis made from the SpaceFlex Shoulder disposable cement molds is
not intended for use more than 180 days, at which time it must be explanted and permanent
devices implanted or another appropriate treatment performed (e.g. resection arthroplasty,
fusion, etc.).
Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (low
viscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicated
for patients who will consistently follow activity limitation throughout the implant period.
The device can exclusively be used by competent healthcare personnel who has complete
scientific and anatomical knowledge.
G21 SRL
900001 104818
In Commercial Distribution
- 08058964726056 ()
- Orthopaedic cement spacer mould
Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold a
temporary hemi- shoulder replacement for skeletally mature patients undergoing a two-stage
revision procedure due to a septic process.
The temporary prosthesis is molded using low viscosity polymethylmethacrylate bone
cement and inserted into the humeral medullary canal and glenoid cavity of the shoulder
following removal of the existing humeral and glenoideal cavity implants and debridement.
SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement.
The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy
(standard treatment approach to an infection).
The hemi-shoulder prosthesis made from the SpaceFlex Shoulder disposable cement molds is
not intended for use more than 180 days, at which time it must be explanted and permanent
devices implanted or another appropriate treatment performed (e.g. resection arthroplasty,
fusion, etc.).
Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (low
viscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicated
for patients who will consistently follow activity limitation throughout the implant period.
The device can exclusively be used by competent healthcare personnel who has complete
scientific and anatomical knowledge.
G21 SRL
900001 104215
In Commercial Distribution
- 08058964726049 ()
- Orthopaedic cement spacer mould
Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold a
temporary hemi- shoulder replacement for skeletally mature patients undergoing a two-stage
revision procedure due to a septic process.
The temporary prosthesis is molded using low viscosity polymethylmethacrylate bone
cement and inserted into the humeral medullary canal and glenoid cavity of the shoulder
following removal of the existing humeral and glenoideal cavity implants and debridement.
SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement.
The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy
(standard treatment approach to an infection).
The hemi-shoulder prosthesis made from the SpaceFlex Shoulder disposable cement molds is
not intended for use more than 180 days, at which time it must be explanted and permanent
devices implanted or another appropriate treatment performed (e.g. resection arthroplasty,
fusion, etc.).
Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (low
viscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicated
for patients who will consistently follow activity limitation throughout the implant period.
The device can exclusively be used by competent healthcare personnel who has complete
scientific and anatomical knowledge.
G21 SRL
900001 084215
In Commercial Distribution
- 08058964724977 ()
- Orthopaedic cement spacer mould
Cook-Swartz Doppler Flow Probe Long Cuff
Cook Vandergrift Inc.
G03014
In Commercial Distribution
- 00827002030145 ()
- 10827002030142 ()
DP-SDP002
- Blood flowmeter catheter, Doppler
Cook-Swartz Doppler Flow Probe Extension Cable
Cook Vandergrift Inc.
G21364
In Commercial Distribution
- 00827002213647 ()
- 10827002213644 ()
DP-CAB01
- Electrical-only medical device connection cable, single-use
Cook-Swartz Doppler Flow Probe Standard Cuff
Cook Vandergrift Inc.
G21363
In Commercial Distribution
- 00827002213630 ()
- 10827002213637 ()
DP-SDP001
- Blood flowmeter catheter, Doppler
Ultra Band-Lok® is intended for use as an orthodontic band cement and for occlusal buildups.
This product is blue shade.
RELIANCE ORTHODONTIC PRODUCTS INC
UBLBPP
In Commercial Distribution
- D798UBLBPP0 ()
UBLBPP
- Dental composite resin