FDA.reportPublic FDA data

N/A

Primary DI
B089B675660
Brand
N/A
Company
BLACK & BLACK SURGICAL, INC.
Model
B67566
Catalog number
B67566
Device description
AUTOCLAVABLE EYE PROTECTION SHIELD W/HANDLE, SMALL, 21X18MM, WHITE OPAQUE, NON-STERILE
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
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
B089B675660PrimaryHIBCC0

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
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
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
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

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
00840329810535N/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
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