FDA.reportPublic FDA data

N/A

Primary DI
B089B621520
Brand
N/A
Company
BLACK & BLACK SURGICAL, INC.
Model
B62152
Catalog number
B62152
Device description
JOSEPH SAW; 7 1/4''(18.5CM), STRAIGHT
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
KBCSAW, NASAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBCSaw, NasalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B089B621520PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Nasal sawA hand-held manual surgical instrument designed for cutting bone and/or cartilage in the nose. It is typically a one-piece metal instrument made of high-grade surgical steel with a handle at the proximal end and a long, thin, serrated blade at the distal end with the cutting teeth set in a straight line, a rounded nose at the tip, and a smooth edge on the top side of the blade to protect tissue not intended to be cut. The instrument is typically used in plastic (i.e., rhinoplasty) and reconstructive procedures of the nose. This is a reusable 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
00840329838669N/AB60360B603602026-10-15
00840329838676BLACK & BLACK SURGICAL, INC.B64037B640372026-09-30
00840329838683BLACK & BLACK SURGICAL, INC.B64040B640402026-09-30
00840329838768BLACK & BLACK SURGICAL, INC.B8BX-TI-1420 PWRB8BX-TI-1420 PWR2026-09-30
00840329838775BLACK & BLACK SURGICAL, INC.B8BX-TI-1632 PWRB8BX-TI-1632 PWR2026-09-30
00840329838928BLACK & BLACK SURGICAL, INC.B8BX-TPIII-3.526 PWRB8BX-TPIII-3.526 PWR2026-09-30
00840329838935BLACK & BLACK SURGICAL, INC.B8BX-TPIII-3.526 PWR CC-TPRB8BX-TPIII-3.526 PWR CC-TPR2026-09-30
00840329838942BLACK & BLACK SURGICAL, INC.B8BX-MER-3.526 PWRB8BX-MER-3.526 PWR2026-09-30
00840329838867N/AB61266B612662026-09-29
00840329838829N/AB99013B990132026-09-28
00840329838959BLACK & BLACK SURGICAL, INC.B8XKCII-3.530L-AHB8XKCII-3.530L-AH2026-09-28
00840329838966BLACK & BLACK SURGICAL, INC.B8BX-EVL-332 ANG PWR-WALLB8BX-EVL-332 ANG PWR-WALL2026-09-28
00840329838973BLACK & BLACK SURGICAL, INC.B8BX-EVL-432 ANG PWR-WALLB8BX-EVL-432 ANG PWR-WALL2026-09-28
00840329838980N/AB99012B990122026-09-28
00840329839000N/AB61013B610132026-09-28
00840329839017N/AB61012B610122026-09-28
00840329838454BLACK & BLACK SURGICAL, INC.B8X-DMER-440-EH ANGB8X-DMER-440-EH ANG2026-07-30
00840329808884N/AB65092B650922022-09-21
00840329808891N/AB65096B650962022-09-21
00840329808907N/AB65097B650972022-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G586E7871320Novo SurgicalNOVO SURGICAL, INC.KBC2023-12-18
G586E7871330Novo SurgicalNOVO SURGICAL, INC.KBC2023-12-18
G586E97871210Novo SurgicalNOVO SURGICAL, INC.KBC2023-12-18
G586E97871220Novo SurgicalNOVO SURGICAL, INC.KBC2023-12-18
G586E97871230Novo SurgicalNOVO SURGICAL, INC.KBC2023-12-18
G586E97871320Novo SurgicalNOVO SURGICAL, INC.KBC2023-12-18
G586E97871330Novo SurgicalNOVO SURGICAL, INC.KBC2023-12-18
00840319753804Hayden MedicalHayden Medical, Inc.KBC2023-10-20
G4252005020My MedicalMy Medical Store LLCKBC2023-08-27
00192896114708Wellenschliff Nasal SawSONTEC INSTRUMENTS, INC.KBC2023-04-28
00842331174797Novo Surgical Inc. NOVO SURGICAL, INC.KBC2022-11-14
00842331158032Novo Surgical Inc. NOVO SURGICAL, INC.KBC2022-11-12
00842331130250Novo Surgical Inc. NOVO SURGICAL, INC.KBC2022-11-10
00840329807320N/ABLACK & BLACK SURGICAL, INC.KBC2022-09-21
00840329807337N/ABLACK & BLACK SURGICAL, INC.KBC2022-09-21
00840329807344N/ABLACK & BLACK SURGICAL, INC.KBC2022-09-21
B089B621500N/ABLACK & BLACK SURGICAL, INC.KBC2022-09-12
B089B621510N/ABLACK & BLACK SURGICAL, INC.KBC2022-09-12
00840319722008Hayden MedicalHayden Medical, Inc.KBC2022-08-08
00840319722015Hayden MedicalHayden Medical, Inc.KBC2022-08-08
00840319707043Hayden MedicalHayden Medical, Inc.KBC2022-07-27
00840319707074Hayden MedicalHayden Medical, Inc.KBC2022-07-27
00840319707081Hayden MedicalHayden Medical, Inc.KBC2022-07-27
04046826472221MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKBC2020-09-24
04046826472238MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKBC2020-09-24
04046826116170MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKBC2020-09-24
04046826116187MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKBC2020-09-24
04046826116194MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKBC2020-09-24
04046826116200MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKBC2020-09-24
04046826116217MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKBC2020-09-24