FDA.report

Power Dental USA

Primary DI
D9435409B00
Brand
Power Dental USA
Company
Power Dental U.S.A. Inc.
Model
5409B
Catalog number
5409B
Device description
X NEEDLE HOLDER CASTROVIEJO STR T/C 16cm X TITANIUM
Published
2022-06-10
Public version status
New
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

Product Code Classifications

CodeDeviceSpecialtyClass
EMDHemostat, SurgicalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D9435409B00PrimaryHIBCC0

GMDN Terms

TermDefinition
Suturing needle holder, reusableA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. 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

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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

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