FDA.report

Power Dental USA

Primary DI
D9435531
Brand
Power Dental USA
Company
Power Dental U.S.A. Inc.
Model
5531
Catalog number
5531
Device description
FORCEPS CASTROVIEJO SPECIAL STR CVD 45' 16.5cm
Published
2021-06-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EMDHEMOSTAT, SURGICAL
FHQHOLDER, NEEDLE, GASTROENTEROLOGIC

Product Code Classifications

CodeDeviceSpecialtyClass
EMDHemostat, SurgicalDental1
FHQHolder, Needle, GastroenterologicGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D9435531PrimaryHIBCC0

GMDN Terms

TermDefinition
Wire/ligature passer, reusableA hand-held, manual surgical instrument designed for passing a length of a flexible material/device, typically a wire, ligature, or orthopaedic graft gauge, through a surgical site by creating a pathway through tissue and facilitating the introduction and handling of the material/device. It may also be referred to as a carrier and is typically in the form of a shaft with a distal clasp, grasping arm, or cannulated hook to hold the material being passed through the tissue. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(815)363-8003info@mydentalusa.com

Regulatory Flags

DUNS number
081305064
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
D943ORCAA0Power Dental USAORCAAORCAA2021-06-20
D94367350Power Dental USA673567352021-06-20
D94367380Power Dental USA673867382021-06-20
D94367390Power Dental USA673967392021-06-20
D94367410Power Dental USA674167412021-06-20
D94367430Power Dental USA674367432021-06-20
D9431007E0Power Dental USA1007E1007E2021-07-13
D94315240Power Dental USA152415242021-06-20
D94335090Power Dental USA350935092021-06-20
D9434826XAS0Power Dental USA4826XAS4826XAS2021-07-13
D94362100Power Dental USA621062102021-06-20
D94364470Power Dental USA644764472022-01-08
D943813050Power Dental USA8130-58130-52021-07-13
D943DCAM0Power Dental USADCAMDCAM2021-07-13
D943DCAM30Power Dental USADCAM3DCAM32021-07-13
D943KIM10Power Dental USAKIM-1KIM-12022-07-12
D943KIM120Power Dental USAKIM-12KIM-122022-07-12
D943KIM20Power Dental USAKIM-2KIM-22022-07-12
D943KIM240Power Dental USAKIM-24KIM-242021-07-13
D943KIM30Power Dental USAKIM-3KIM-32022-07-12

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
G453230117BCL0PEAK MEDICALPeak Medical Distribution Inc.FHQ2026-03-23
G453230117BCR0PEAK MEDICALPeak Medical Distribution Inc.FHQ2026-03-23
04059453049339Hermann Medizintechnik GmbHHermann Medizintechnik GmbHFHQ2026-03-10
B382SD9056641000Surgical DirectSurgical Direct, Inc.FHQ2026-03-09
B382SD9056791000Surgical DirectSurgical Direct, Inc.FHQ2026-03-09
G1493806608TBS DentalACME ENTERPRISE.EMD2026-03-02
G1493807609TBS DentalACME ENTERPRISE.EMD2026-03-02
00192896106833Matthieu Needle HolderSONTEC INSTRUMENTS, INC.FHQ2026-02-26
B382SD905662170Surgical DirectSurgical Direct, Inc.FHQ2026-02-20
G4254202130My MedicalMy Medical Store LLCFHQ2026-02-17
G4254202200My MedicalMy Medical Store LLCFHQ2026-02-17
G4254202240My MedicalMy Medical Store LLCFHQ2026-02-17
B382SD905434160Surgical DirectSurgical Direct, Inc.FHQ2026-02-05
B382SD90548817LH0Surgical DirectSurgical Direct, Inc.FHQ2026-02-05
B382SD9055891110Surgical DirectSurgical Direct, Inc.FHQ2026-02-05
B382SD9056791160Surgical DirectSurgical Direct, Inc.FHQ2026-02-05
B382SD9084551100Surgical DirectSurgical Direct, Inc.FHQ2026-02-05
00192896122628Glasser Micro Needle HolderSONTEC INSTRUMENTS, INC.FHQ2026-01-22
00192896122673Derf Needle HolderSONTEC INSTRUMENTS, INC.FHQ2026-01-22
00848657076012AED 6250 Mathieu Handle Laparoscopic Needle Holder, 33cm, Curved Left JawNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FHQ2026-01-15
00848657076029AED 6252 Mathieu Handle Laparoscopic Needle Holder, 33cm, Curved Right JawNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FHQ2026-01-15
D928301140LH0NEEDLE HOLDER MAYO-HEGAR 7" LEFT HAND TCW.H. Holden, Inc.FHQ2026-01-05
D9283011450NEEDLE HOLDER MAYO-HEGAR 8" / 20CM TCW.H. Holden, Inc.FHQ2026-01-05
D9283011510NEEDLE HOLDER OLSEN-HEGAR 4 1/2" TCW.H. Holden, Inc.FHQ2026-01-05
D9283011570NEEDLE HOLDER OLSEN-HEGAR 7 1/4" TCW.H. Holden, Inc.FHQ2026-01-05
D9283011600NEEDLE HOLDER RYDER 5 1/8" TCW.H. Holden, Inc.FHQ2026-01-05
D9283011640NEEDLE HOLDER FRENCH RYDER 9" TCW.H. Holden, Inc.FHQ2026-01-05
D9283011650NEEDLE HOLDER HEANEY 8 1/4" - 20CMW.H. Holden, Inc.FHQ2026-01-05
D928301173OS0NEEDLE HOLDER MINI-RYDER 6" SM OFF SET HANDLEW.H. Holden, Inc.FHQ2026-01-05
D92830117470NEEDLE HOLDER MINI-RYDER 7" TC NEW PATTERNW.H. Holden, Inc.FHQ2026-01-05