FDA.reportPublic FDA data

N/A

Primary DI
00840329810535
Brand
N/A
Company
BLACK & BLACK SURGICAL, INC.
Model
B67561
Catalog number
B67561
Device description
AUTOCLAVABLE EYE PROTECTION SHIELD W/SILICONE SUCTION CUP, SMALL, 21X18MM, WHITE OPAQUE, NON-STERILE
Published
2022-09-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HQHEYE, ARTIFICIAL, NON-CUSTOM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQHEye, Artificial, Non-CustomOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840329810535PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840329810535008403298105358403298105350840329810535

GMDN Terms#

Term, Definition table
TermDefinition
Radiation/mechanical corneal shield, reusableA protective device intended to be placed on the cornea of a patient to protect the eyes from physical damage and/or exposure to primary and scattered radiation during a medical procedure [e.g., periorbital surgery, x-ray/CT scan, dermatological laser treatment]. It is typically in the form of a dome and is made of non-biodegradable, durable materials (e.g., lead, tungsten, glass, plastic) that provide mechanical protection and/or prevent the transmission of harmful radiation to the eyes. 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
true
Premarket exempt
true
Lot or batch
true
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
PROSV2623Soper Brothers CustomSoper Brothers, IncorporatedHQH2026-03-03
SHELLV2627Soper Brothers CustomSoper Brothers, IncorporatedHQH2026-03-03
G568V2623Artificial Eye, Plastic, CustomTHOMPSON OCULAR PROSTHETICS, INC.HQH2025-03-10
B796V2623Eye, Artificial, Non-CustomMIDWEST EYE LABORATORIES, INC.HQH2024-03-27
G6011000Sil-OphthoSIL-OPHTHO, LLCHQH2024-03-14
G601100T0Sil-OphthoSIL-OPHTHO, LLCHQH2024-03-14
G6013500Sil-OphthoSIL-OPHTHO, LLCHQH2024-03-14
G601350T0Sil-OphthoSIL-OPHTHO, LLCHQH2024-03-14
G519V2623Eye, Artificial, Non-CustomMidwest Eye Laboratories Sioux Falls, LLCHQH2024-03-10
G290V2623Eye, Artificial, Non-CustomMidwest Eye Laboratories Woodbury, LLCHQH2024-02-19
G542V26230Artificial EyeTHE EYE CONCERN, INC.HQH2024-01-10
G521V2623Artificial Eye, Plastic, CustomLegrand AssociatesHQH2023-10-18
00840329810528N/ABLACK & BLACK SURGICAL, INC.HQH2022-09-21
00840329810542N/ABLACK & BLACK SURGICAL, INC.HQH2022-09-21
00840329810559N/ABLACK & BLACK SURGICAL, INC.HQH2022-09-21
00840329810566N/ABLACK & BLACK SURGICAL, INC.HQH2022-09-21
00840329810573N/ABLACK & BLACK SURGICAL, INC.HQH2022-09-21
00840329810580N/ABLACK & BLACK SURGICAL, INC.HQH2022-09-21
00840329810597N/ABLACK & BLACK SURGICAL, INC.HQH2022-09-21
00840329810603N/ABLACK & BLACK SURGICAL, INC.HQH2022-09-21
B089B675600N/ABLACK & BLACK SURGICAL, INC.HQH2022-09-12
B089B675610N/ABLACK & BLACK SURGICAL, INC.HQH2022-09-12
B089B675620N/ABLACK & BLACK SURGICAL, INC.HQH2022-09-12
B089B675630N/ABLACK & BLACK SURGICAL, INC.HQH2022-09-12
B089B675650N/ABLACK & BLACK SURGICAL, INC.HQH2022-09-12
B089B675660N/ABLACK & BLACK SURGICAL, INC.HQH2022-09-12
B089B675670N/ABLACK & BLACK SURGICAL, INC.HQH2022-09-12
B089B675680N/ABLACK & BLACK SURGICAL, INC.HQH2022-09-12
B089B675690N/ABLACK & BLACK SURGICAL, INC.HQH2022-09-12
B863E661087V2623Artificial Eye, Plastic, CustomTEXAS EYE PROSTHETICS LLCHQH2020-04-14