FDA.reportPublic FDA data

N/A

Primary DI
B089B547010
Brand
N/A
Company
BLACK & BLACK SURGICAL, INC.
Model
B54701
Catalog number
B54701
Device description
STRABISMUS ONYX SCISSORS; 4 1/2''(11.5CM), 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
EGNSCISSORS, SURGICAL TISSUE, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGNScissors, Surgical Tissue, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B089B547010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical scissors, reusableA non-dedicated, hand-held manual surgical instrument designed to cut a variety of tissues during open surgery; it is not dedicated to surgery at a specific anatomy/body orifice nor does it have a single clinical intended use. It might in addition be intended for cutting sutures or other materials associated with surgery. It is comprised of two pivoted shearing blades with handles, whereby the blades cut as the sharpened edges pass one another as they are closed. It is typically made of metal and is available in various designs and sizes, and some types can have carbide inserts along the cutting edges. This is a reusable device intended to be sterilized prior to use.

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
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
00840329808914N/AB65099B650992022-09-21
00840329807306N/AB62124B621242022-09-21
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
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

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Primary DI, Brand, Company table
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B382SD9032191050Surgical DirectSurgical Direct, Inc.EGN2026-08-07
B382SD9034951000Surgical DirectSurgical Direct, Inc.EGN2026-08-07
B382SD9034951010Surgical DirectSurgical Direct, Inc.EGN2026-08-07
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B382SD488610020Surgical DirectSurgical Direct, Inc.EGN2026-08-03
B382S7941000Surgical DirectSurgical Direct, Inc.EGN2026-07-31
00840183532413BR Surgical, LLCBR Surgical, LLCEGN2026-07-17
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B382SD903988102SC0Surgical DirectSurgical Direct, Inc.EGN2026-07-14
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B382S37841020Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382S37842000Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382S37935000Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD903070100SC0Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD903071100SC0Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD90315118T0Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD9034541060Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD9035521000Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD9035651000Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD9037861000Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD9037871010Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD903797030Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD903870060Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD9039790010Surgical DirectSurgical Direct, Inc.EGN2026-06-10