FDA.reportPublic FDA data

N/A

Primary DI
B089B631040
Brand
N/A
Company
BLACK & BLACK SURGICAL, INC.
Model
B63104
Catalog number
B63104
Device description
FOX DERMAL CURETTE; 5 1/2''(14CM), 5MM
Published
2022-09-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZSCURETTE, SURGICAL, GENERAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZSCurette, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B089B631040PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(770)414-4880info@blackandblacksurgical.com

Regulatory Flags#

DUNS number
004382282
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840329838225BLACK & BLACK SURGICAL, INC.B8XBAS-432BH-AH-RTB8XBAS-432BH-AH-RT2026-06-08
00840329838232BLACK & BLACK SURGICAL, INC.B8XIII-332BH-AH-RTB8XIII-332BH-AH-RT2026-06-08
00840329838249BLACK & BLACK SURGICAL, INC.B8XIII-432BH-AH-RTB8XIII-432BH-AH-RT2026-06-08
00840329805982N/AB61115B611152022-09-21
00840329806033N/AB61126B611262022-09-21
00840329813369N/AB61112-ALB61112-AL2022-09-21
00840329813376N/AB61112SB61112S2022-09-21
00840329813512N/AB61120SB61120S2022-09-21
00840329837365BLACK & BLACK SURGICAL, INC.B89LL1.2B89LL1.22026-05-04
00840329837372BLACK & BLACK SURGICAL, INC.B89LL1.4B89LL1.42026-05-04
00840329802592N/AB54790B547902022-09-21
00840329811518N/AB79808B798082022-09-21
00840329811525N/AB79809B798092022-09-21
B089B784600Headlight CableB78460B784602016-07-29
B089B784640Headlight CableB78464B784642016-07-29
B089B797180Fiberoptic Cable B79718B797182016-07-29
B089B797190Fiberoptic Cable B79719B797192016-07-29
B089B797220Fiberoptic Cable B79722B797222016-07-29
B089B797230Fiberoptic Cable B79723B797232016-07-29
B089B797240Fiberoptic Cable B79724B797242016-07-29

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