FDA.report

N/A

Primary DI
00840329807702
Brand
N/A
Company
BLACK & BLACK SURGICAL, INC.
Model
B63104
Catalog number
B63104
Device description
FOX DERMAL CURETTE; 5 1/2''(14CM), 5MM
Published
2022-09-21
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

Related Records

Product Codes

CodeName
FZSCURETTE, SURGICAL, GENERAL USE

Product Code Classifications

CodeDeviceSpecialtyClass
FZSCurette, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840329807702PrimaryGS10

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
Moist Heat or Steam Sterilization

Contacts

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 DIBrandModelCatalogPublished
00840329836924Black & Black SurgicalB60039B600392026-03-05
00840329837457N/AB80050B800502026-03-05
00840329837464N/AB80051B800512026-03-04
00840329836795N/AB8XFIC-V-CC1218-LLB8XFIC-V-CC1218-LL2026-01-16
00840329837013N/AB8XIII-526L-AHB8XIII-526L-AH2026-01-16
00840329836375N/AB8XLVH-640L-AHB8XLVH-640L-AH2026-01-15
00840329836382N/AB8BX-DBAS-523 PWRB8BX-DBAS-523 PWR2026-01-15
00840329836399N/AB8BX-DBAS-530 PWRB8BX-DBAS-530 PWR2026-01-15
00840329836405N/AB8BX-DMER-523 PWRB8BX-DMER-523 PWR2026-01-15
00840329836412N/AB8XDBAS-530LB8XDBAS-530L2026-01-15
00840329836429N/AB8XSPA-1120-LLB8XSPA-1120-LL2026-01-15
00840329836443N/AB8XFAN-149-LLB8XFAN-149-LL2026-01-15
00840329836450N/AB8BX-BAS-432 PWR BARBB8BX-BAS-432 PWR BARB2026-01-15
00840329836467N/AB8XFIC-I-CC1810-LLB8XFIC-I-CC1810-LL2026-01-15
00840329836474N/AB8XSPA-CC1810-LLB8XSPA-CC1810-LL2026-01-15
00840329836481N/AB8XMLV-1215-LLB8XMLV-1215-LL2026-01-15
00840329836498N/AB8AX-MIII-432 MLRB8AX-MIII-432 MLR2026-01-15
00840329836504N/AB8XMER-215-SHB8XMER-215-SH2026-01-15
00840329836542N/AB8BX-BAS-540 ANG PWRB8BX-BAS-540 ANG PWR2026-01-15
00840329836559BLACK & BLACK SURGICAL, INC.B8BX-III-432 PWR RTB8BX-III-432 PWR RT2026-01-15

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
M93071015043S20Life Instruments Life Instrument CorporationFZS2026-03-23
M93071015044S20Life InstrumentsLife Instrument CorporationFZS2026-03-23
04052536215539tezoUlrich GmbH & Co. KGFZS2026-03-16
04052536215546tezoUlrich GmbH & Co. KGFZS2026-03-16
00810130207367MSIModern Surgical Instruments LLCFZS2026-03-12
00810130207374MSIModern Surgical Instruments LLCFZS2026-03-12
00810130207381MSIModern Surgical Instruments LLCFZS2026-03-12
00810130207398MSIModern Surgical Instruments LLCFZS2026-03-12
04052536017560tezoUlrich GmbH & Co. KGFZS2026-03-12
04052536017577tezoUlrich GmbH & Co. KGFZS2026-03-12
04052536017584tezoUlrich GmbH & Co. KGFZS2026-03-12
04052536017751tezoUlrich GmbH & Co. KGFZS2026-03-12
00810158219182PRINCETONPrinceton Medical Group, Inc.FZS2026-03-11
00810158219199PRINCETONPrinceton Medical Group, Inc.FZS2026-03-11
M93071015043SAT20Life InstrumentsLife Instrument CorporationFZS2026-03-06
M93071015044SAT20Life InstrumentsLife Instrument CorporationFZS2026-03-06
00810158218802PRINCETONPrinceton Medical Group, Inc.FZS2026-02-05
04059453143389Hermann Medizintechnik GmbHHermann Medizintechnik GmbHFZS2026-02-02
M9307120160110Life Instruments Life Instrument CorporationFZS2026-02-02
00810158218598PRINCETONPrinceton Medical Group, Inc.FZS2026-01-16
00810158218604PRINCETONPrinceton Medical Group, Inc.FZS2026-01-16
00841731142474Hintermann Series VILEX LLCFZS2026-01-16
00810158218505PRINCETONPrinceton Medical Group, Inc.FZS2026-01-15
M930712150000Life InstrumentsLife Instrument CorporationFZS2026-01-09
M930712150010Life InstrumentsLife Instrument CorporationFZS2026-01-09
M9307121501110Life InstrumentsLife Instrument CorporationFZS2026-01-09
M930712150200Life InstrumentsLife Instrument CorporationFZS2026-01-09
M930712150210Life InstrumentsLife Instrument CorporationFZS2026-01-09
M930712150300Life InstrumentsLife Instrument CorporationFZS2026-01-09
M930712150310Life InstrumentsLife Instrument CorporationFZS2026-01-09