FDA.report

SCOTT'S PREMIUM GERMAN TISSUE PUNCH 5mm

Primary DI
D77819064260
Brand
SCOTT'S PREMIUM GERMAN TISSUE PUNCH 5mm
Company
SCOTT'S DENTAL SUPPLY L.L.C.
Model
190-6426
Catalog number
190-6426
Device description
SCOTT'S PREMIUM GERMAN TISSUE PUNCH 5mm
Published
2021-02-27
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

Contact Domains

Product Codes

CodeName
EMEPUNCH, BIOPSY, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
EMEPunch, Biopsy, SurgicalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D77819064260PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental soft-tissue coring punch, reusableA dental instrument designed to remove with precision a circular section of oral soft tissue (e.g., gum, palatal mucosa) during dental surgery, typically to allow access to a site for drilling and dental/orthodontic implant placement without the use of a scalpel. Sometimes referred to as a mucotome, it will typically be designed with a handle at the proximal end for manual operation or for mounting into a dental power tool (e.g., contra-angle low-speed drill handpiece), and have a cylindrical hollow tube-like head with a sharp cutting at the distal end. It is typically made of high-grade stainless steel. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)901-3368info@scottsdental.com

Regulatory Flags

DUNS number
137217043
Device count
1
DM exempt
true
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
false
Sterilization required before use
true

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