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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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Tapered Screw-Vent® - 00889024014596

No Description
ZIMMER DENTAL INC.
DHT3/5
In Commercial Distribution

  • 00889024014596 ()

  • Ø3.5mm; Ø5.5mm


  • Dental implant suprastructure, temporary, preformed, single-use

AMPLIM - 00810477026416

AMPLIM Ovulation Test Kit (20 Ovulation Test+ 5 Early Pregnancy Tests)
AMPLIM, LLC
A8177W-20+5
In Commercial Distribution

  • 00810477026416 ()


  • Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

AMPLIM - 00810477026287

AMPLIM Ovulation Test Kit (20 Ovulation Test+ 5 Early Pregnancy Tests)
AMPLIM, LLC
A8177-20+5
In Commercial Distribution

  • 00810477026287 ()


  • Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

Dental unit - 06974416450053

No Description
FOSHAN SAFETY MEDICAL EQUIPMENT CO.,LTD.
Mare.5
In Commercial Distribution

  • 06974416450053 ()


  • Dental delivery system instrument unit, electric

Exploro Vaginal Health pH Test Device - 06974246462288

No Description
Safecare Biotech (Hangzhou) Co., Ltd.
5 Tests
In Commercial Distribution

  • 06974246462288 ()
PH-6012

  • Vaginal pH screening IVD, kit, rapid colorimetric, clinical

Exploro Highly Sensitive Urine Drug Test (5-Panel) - 06974246462134

No Description
Safecare Biotech (Hangzhou) Co., Ltd.
5 tests
In Commercial Distribution

  • 06974246462134 ()
MDP-1054

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

T Testahead Multi-Drug Urine Test Dip Card - 06974246461618

No Description
Safecare Biotech (Hangzhou) Co., Ltd.
5 tests
In Commercial Distribution

  • 06974246461618 ()
MDP-1064

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

T Testahead Multi-Drug Urine Test Dip Card - 06974246461595

No Description
Safecare Biotech (Hangzhou) Co., Ltd.
5 tests
In Commercial Distribution

  • 06974246461595 ()
MDP-1124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

FIRSTVIEW Fentanyl Urine Test Cassette - 06974246461496

No Description
Safecare Biotech (Hangzhou) Co., Ltd.
5 tests
In Commercial Distribution

  • 06974246461496 ()
FYL-1012

  • Fentanyl IVD, kit, rapid ICT, clinical

T Testahead Cotinine(COT) Urine Test Dipcard - 06974246461489

No Description
Safecare Biotech (Hangzhou) Co., Ltd.
5 tests
In Commercial Distribution

  • 06974246461489 ()
COT-1014

  • Nicotine/nicotine metabolite IVD, kit, rapid colorimetric, clinical
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