| Primary Device ID | D943G5505BN0 |
| NIH Device Record Key | 88e187e3-a247-48a6-a3b2-cf86e64b97f1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Garg |
| Version Model Number | G5505BN |
| Catalog Number | G5505BN |
| Company DUNS | 081305064 |
| Company Name | Power Dental U.S.A. Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | +1(800)286-1635 |
| info@medequipdental.com | |
| Phone | +1(800)286-1635 |
| info@medequipdental.com | |
| Phone | +1(800)286-1635 |
| info@medequipdental.com | |
| Phone | +1(800)286-1635 |
| info@medequipdental.com | |
| Phone | +1(800)286-1635 |
| info@medequipdental.com | |
| Phone | +1(800)286-1635 |
| info@medequipdental.com | |
| Phone | +1(800)286-1635 |
| info@medequipdental.com | |
| Phone | +1(800)286-1635 |
| info@medequipdental.com | |
| Phone | +1(800)286-1635 |
| info@medequipdental.com | |
| Phone | +1(800)286-1635 |
| info@medequipdental.com | |
| Phone | +1(800)286-1635 |
| info@medequipdental.com | |
| Phone | +1(800)286-1635 |
| info@medequipdental.com | |
| Phone | +1(800)286-1635 |
| info@medequipdental.com | |
| Phone | +1(800)286-1635 |
| info@medequipdental.com | |
| Phone | +1(800)286-1635 |
| info@medequipdental.com | |
| Phone | +1(800)286-1635 |
| info@medequipdental.com | |
| Phone | +1(800)286-1635 |
| info@medequipdental.com | |
| Phone | +1(800)286-1635 |
| info@medequipdental.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D943G5505BN0 [Primary] |
| EMD | Hemostat, Surgical |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D943G5505BN0]
Moist Heat or Steam Sterilization
[D943G5505BN0]
Moist Heat or Steam Sterilization
[D943G5505BN0]
Moist Heat or Steam Sterilization
[D943G5505BN0]
Moist Heat or Steam Sterilization
[D943G5505BN0]
Moist Heat or Steam Sterilization
[D943G5505BN0]
Moist Heat or Steam Sterilization
[D943G5505BN0]
Moist Heat or Steam Sterilization
[D943G5505BN0]
Moist Heat or Steam Sterilization
[D943G5505BN0]
Moist Heat or Steam Sterilization
[D943G5505BN0]
Moist Heat or Steam Sterilization
[D943G5505BN0]
Moist Heat or Steam Sterilization
[D943G5505BN0]
Moist Heat or Steam Sterilization
[D943G5505BN0]
Moist Heat or Steam Sterilization
[D943G5505BN0]
Moist Heat or Steam Sterilization
[D943G5505BN0]
Moist Heat or Steam Sterilization
[D943G5505BN0]
Moist Heat or Steam Sterilization
[D943G5505BN0]
Moist Heat or Steam Sterilization
[D943G5505BN0]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-03-08 |
| Device Publish Date | 2023-02-28 |
| D943GSFT0 | GARG SOFT TISSUE KIT (12 PCS) |
| D943GMSK0 | GARG MINI SINUS KIT (7 PCS) |
| D943GIMP0 | GARG BASIC IMPLANT KIT (16 PCS) |
| D943GEXT0 | GARG EXTRACTION KIT (15 PCS) |
| D943GECRP0 | ROOT TIP PICK SET (6 PCS) |
| D943GCON0 | GARG CONTINUUM KIT (6 PCS) |
| D943GCLK0 | GARG CROWN LENGTHENING KIT (13 PCS) |
| D943GARG0 | GARG SINUS LIFT KIT (19PCS) |
| D943G9032BBG0 | BONE GRAFT/PACKER SET (7 PCS) |
| D943G7512N0 | X CASSETTES SURGICAL / UTILITY MORE THAN 15 HAND INSTRUMENTS WITH PARTITION ACCESSORY RACK. OR A |
| D943G75110 | CASSETTES SURGICAL / UTILITY 7" L X 8" W X 1 1/4" D (174 X 203 X 31mm H) |
| D943G7503U0 | CASSETTES DOUBLE HINGE UTILITY 90 X 203 X 31mm |
| D943G7503P0 | X CASSETTES OPEN TYPE SURGICAL / UTILITY MORE THAN 7 HAND INSTRUMENTS OR ANY INSTRUMENTS HOLD. 2 |
| D943G74260 | BONE TRAY BOWL 58mm OUT SIZE x 28mm DEPTH |
| D943G7018N0 | SYRINGES ASPIRATED 1.8ml WING, RECOMMEND USE OF PLASTIC NEEDLES (NOT ALUMINIUM) |
| D943G69620 | MIRROR WITH MIRROR HANDLE, MIRROR #5 C/S FRONT SURFACE WITH MIRROR HANDLE 6EZ C/S (6951+6911) FO |
| D943G69050 | SCALPEL HANDLE 5 ROUND HANDLE STR |
| D943G67170 | FRAZIER ASPIRATOR SUCTION TIP FRENCH STYLE WITH CONTROL RELIEF HOLE 4.0mm |
| D943G6525G0 | TWEEZERS, SURGICAL TISSUE FORCEPS GERALD STR MICRO VERSION 18cm |
| D943G65110 | TWEEZERS SUTURE CORN TISSUE FORCEPS CVD 16cm REGULAR |
| D943G65010 | TWEEZERS, TISSUE FORCEPS ADSON STR 12cm |
| D943G64360 | RETRACTORS WEIDER TONGUE 30mm |
| D943G64230 | RETRACTORS CAWOOD MINNESOTA |
| D943G64200 | RETRACTORS UNIVERSITY OF MINNESOTA |
| D943G59220 | SUTURE SCISSORS SLIM 15cm |
| D943G5917B0 | SCISSORS SUPER CUT LA GRANGE CVD 11.5cm PREMIUM SUTURE BLACK EDITION |
| D943G5916S0 | SCISSORS SUPER CUT GOLDMAN-FOX SPECIAL CVD 12.5cm |
| D943G5907S0 | SCISSORS SUPER CUT DEAN 17.5cm |
| D943G5505BN0 | NEEDLE HOLDER T/C CRILE-WOOD 15cm TITANIUM X |
| D943G54020 | NEEDLE HOLDER CRILE-MURRAY 15cm |
| D943G5310C0 | HEMOSTATIC FORCEPS CRILE/KELLY 14cm CVD |
| D943G5303C0 | HEMOSTATIC FORCEPS HALSTED-MOSQUITO 12.5cm CVD. 028 - O |
| D943G49850 | EXTRACTION FORCEPS F12 UPPER MOLAR R |
| D943G49840 | EXTRACTION FORCEPS F11 UPPER MOLAR L |
| D943G4980C0 | EXTRACTION FORCEPS F7C LOWER MOLAR |
| D943G49790 | EXTRACTION FORCEPS ATRAUMATIC F6 UPPER MOLARS |
| D943G49780 | EXTRACTION FORCEPS F5 LOWER ANTERIOR |
| D943G49760 | EXTRACTION FORCEPS F3 UPPER ANTERIOR |
| D943G4826AF0 | EXTRACTION FORCEPS AMERICAN 151AF LOWER PREMOLAR |
| D943G4823AF0 | EXTRACTION FORCEPS AMERICAN 150AF UPPER PREMOLAR |
| D943G48110 | EXTRACTION FORCEPS A-TRAUMATIC AMERICAN 23 LOWER 1st and 2nd MOLAR. COW HORN |
| D943G46290 | ENDO FINGER RULER (1mm~38mm) |
| D943G46130 | CALIPER CASTRO 8.5cm |
| D943G44080 | BONE RONGEURS FRIEDMAN 14CM |
| D943G41110 | SURGICAL CURETTES MOLT2/4 |
| D943G39180 | ROOT TIP PICKS HOWARD3 DELICATE, AVOID EXCESSIVE PRESSURE, NOT TO BE USED AS AN ELEVATOR |
| D943G39170 | ROOT TIP PICKS HOWARD2 DELICATE, AVOID EXCESSIVE PRESSURE, NOT TO BE USED AS AN ELEVATOR |
| D943G39160 | ROOT TIP PICKS HOWARD1 DELICATE, AVOID EXCESSIVE PRESSURE, NOT TO BE USED AS AN ELEVATOR |
| D943G37510 | LUXATION 2mm STR DELICATE, AVOID EXCESSIVE PRESSURE, NOT TO BE USED AS AN ELEVATOR |
| D943G37300 | ELEVATORS CRYER L 46R |