FDA.reportPublic FDA data

N/A

Primary DI
00840329807306
Brand
N/A
Company
BLACK & BLACK SURGICAL, INC.
Model
B62124
Catalog number
B62124
Device description
BALLENGER SWIVEL KNIFE; 8 1/4''(21CM), STRAIGHT, 4MM BLADE
Published
2022-09-21
Public version status
Update
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
KASKNIFE, NASAL

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840329807306PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840329807306008403298073068403298073060840329807306

GMDN Terms#

Term, Definition table
TermDefinition
Cartilage knifeA hand-held manual surgical instrument designed for cutting, shaving or shaping cartilage during a surgical intervention. It is typically a one-piece instrument with a sharp, single-edged, cutting blade at the distal end which is normally very long, similar in shape to a scalpel blade, and may vary in length and size; it has a handle at the proximal end. It is normally made of high-grade stainless steel. Also known as a chondrotome, a cartilage knife can also be used in pathology procedures. 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
00840329830397ASPIRATION TUBINGB89205B892052026-07-30
00840329834494BLACK & BLACK SURGICAL, INC.B89113B891132026-07-30
00840329836856BLACK & BLACK SURGICAL, INC.B89217B892172026-07-30
00840329837648ASPIRATION TUBINGB89206B892062026-07-30
00840329838409BLACK & BLACK SURGICAL, INC.B8XBAS-332L-ANGB8XBAS-332L-ANG2026-07-30
00840329838416BLACK & BLACK SURGICAL, INC.B8XCC-332L-AHB8XCC-332L-AH2026-07-30
00840329838430BLACK & BLACK SURGICAL, INC.B8BX-DMER-632 PWRB8BX-DMER-632 PWR2026-07-30
00840329838454BLACK & BLACK SURGICAL, INC.B8X-DMER-440-EH ANGB8X-DMER-440-EH ANG2026-07-30
00840329838515BLACK & BLACK SURGICAL, INC.B8XSTD-515-SYRB8XSTD-515-SYR2026-07-30
00840329800277N/AB89107B891072022-09-21
00840329800291N/AB89109B891092022-09-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776422622MillenniumAvalign Technologies, Inc.KAS2026-08-03
09348811143594INKAThe Trustee for KAISER FAMILY TRUSTKAS2026-03-18
09348811155153INKAThe Trustee for KAISER FAMILY TRUSTKAS2025-11-28
00810207783169Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAS2025-11-24
00810207783176Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAS2025-11-24
00810207783183Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAS2025-11-24
00810207783190Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAS2025-11-24
00810207783206Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAS2025-11-24
00810207783213Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAS2025-11-24
00810207783220Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAS2025-11-24
00810207783237Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAS2025-11-24
00810207783244Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAS2025-11-24
00810207783251Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAS2025-11-24
00190776414238MillenniumAvalign Technologies, Inc.KAS2025-10-22
00194613047528MSI Precision Specialty InstrumentsMed Saver, Inc.KAS2025-08-01
04049047120292GimmiGimmi GmbHKAS2025-05-21
04049047120339GimmiGimmi GmbHKAS2025-05-21
04049047120360GimmiGimmi GmbHKAS2025-05-21
04049047120407GimmiGimmi GmbHKAS2025-05-21
00194613100285MSI Precision Specialty InstrumentsMed Saver, Inc.KAS2025-03-21
00194613089689MSI Precision Specialty InstrumentsMed Saver, Inc.KAS2024-08-15
00194613090821MSI Precision Specialty InstrumentsMed Saver, Inc.KAS2024-08-15
00840306812361Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KAS2024-02-13
00840306812378Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KAS2024-02-13
00840306812385Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KAS2024-02-13
G586E97860210Novo SurgicalNOVO SURGICAL, INC.KAS2023-12-18
G586E97860220Novo SurgicalNOVO SURGICAL, INC.KAS2023-12-18
G586E97860230Novo SurgicalNOVO SURGICAL, INC.KAS2023-12-18
00190776046965AvalignAvalign Technologies, Inc.KAS2023-11-13
00190776046972AvalignAvalign Technologies, Inc.KAS2023-09-28