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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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MedGyn Pessary Ring w/support #5 - M803050030

Pessary ring is used to treat uterine prolapse.
MEDGYN PRODUCTS, INC.
Pessary Ring w/support #5
In Commercial Distribution

  • M803050030 ()
050030

  • Pelvic-organ-supporting pessary

Tinto Cytokeratin 5 & 6 & ERG, RMab - B502BSB66200

Cytokeratin 5 & 6 & ERG is a rabbit monoclonal antibody cocktail derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5.
BIO SB, INC.
Predilute, 15 ml
In Commercial Distribution

  • B502BSB66200 ()
BSB 6620

  • Cytokeratin IVD, antibody

Tinto Cytokeratin 5 & 6 & ERG, RMab - B502BSB66190

Cytokeratin 5 & 6 & ERG is a rabbit monoclonal antibody cocktail derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5.
BIO SB, INC.
Predilute, 7 ml
In Commercial Distribution

  • B502BSB66190 ()
BSB 6619

  • Cytokeratin IVD, antibody

Tinto Cytokeratin 5 & 6 & ERG, RMab - B502BSB66180

Cytokeratin 5 & 6 & ERG is a rabbit monoclonal antibody cocktail derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5.
BIO SB, INC.
Predilute, 3 ml
In Commercial Distribution

  • B502BSB66180 ()
BSB 6618

  • Cytokeratin IVD, antibody

Aspire Max 5 Aspiration Catheter 55cm - B090A50550

ASPIRE MAX 5 Mechanical Thrombectomy Systems™ for removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
A5-055
Not in Commercial Distribution

  • B090A50552 ()
  • B090A50551 ()
  • B090A50550 ()
A5-055

  • General-purpose syringe, single-use
  • Thrombectomy suction catheter

VINTAGE PRO COLOR EFFECT RED 5 - E235P04240

VINTAGE PRO COLOR EFFECT RED 5
SHOFU DENTAL CORPORATION
P0424
In Commercial Distribution

  • E235P04240 ()
P0424

  • Dental porcelain/ceramic restoration kit

VINTAGE PRO COLOR EFFECT MLV 5 - E235P04230

VINTAGE PRO COLOR EFFECT MLV 5
SHOFU DENTAL CORPORATION
P0423
In Commercial Distribution

  • E235P04230 ()
P0423

  • Dental porcelain/ceramic restoration kit

VINTAGE PRO ENAM EFFECT DC-T 5 - E235P03610

VINTAGE PRO ENAM EFFECT DC-T 5
SHOFU DENTAL CORPORATION
P0361
In Commercial Distribution

  • E235P03610 ()
P0361

  • Dental porcelain/ceramic restoration kit

VINTAGE PRO ENAM EFFECT CC-T 5 - E235P03600

VINTAGE PRO ENAM EFFECT CC-T 5
SHOFU DENTAL CORPORATION
P0360
In Commercial Distribution

  • E235P03600 ()
P0360

  • Dental porcelain/ceramic restoration kit

VINTAGE PRO ENAM EFFECT BC-T 5 - E235P03590

VINTAGE PRO ENAM EFFECT BC-T 5
SHOFU DENTAL CORPORATION
P0359
In Commercial Distribution

  • E235P03590 ()
P0359

  • Dental porcelain/ceramic restoration kit
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