FDA.report

N/A

Primary DI
B58210572460
Brand
N/A
Company
GEORGE TIEMANN & CO.
Model
1057246
Catalog number
1057246
Device description
Curettes
Published
2020-09-24
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
HTFCURETTE

Product Code Classifications

CodeDeviceSpecialtyClass
HTFCuretteGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B58210572460PrimaryHIBCC0

GMDN Terms

TermDefinition
Dermal curetteA sterile, hand-held manual surgical instrument designed exclusively for the precise scraping and/or excising of skin/dermal tissue (e.g., for treatment of superficial warts or wounds). It is available in a variety of shapes/sizes and has an appropriately-shaped distal end (e.g., ring-like). This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(631)273-0005stephen@georgetiemann.com

Regulatory Flags

DUNS number
107043630
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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
false

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B582070609STFRA0N/A070609STFRA070609STFRA2020-09-24
B5820800800N/A80080800802020-09-24
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B582080090450N/A800904580090452020-09-24
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B582080091620N/A800916280091622020-09-24
B5820800950N/A80095800952020-09-24
B58208009910N/A8009918009912020-09-24
B58208009930N/A8009938009932020-09-24
B58208009940N/A8009948009942020-09-24
B58208009950N/A8009958009952020-09-24

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