FDA.reportPublic FDA data

N/A

Primary DI
00840329811105
Brand
N/A
Company
BLACK & BLACK SURGICAL, INC.
Model
B78483
Catalog number
B78483
Device description
VOROTEK "O SCOPE" - HEADBAND STNDRD KIT-AUDIOL; 3 DIOPTER, 10HR BATT PK, CHRGER: RECOMM FOR MULTI
Published
2022-09-21
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
EBALIGHT, SURGICAL HEADLIGHT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBALight, Surgical HeadlightDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840329811105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840329811105008403298111058403298111050840329811105

GMDN Terms#

Term, Definition table
TermDefinition
Head-worn lampAn electrically-powered lamp mounted on a headband, helmet frame, or spectacles and intended to provide light directly onto the field of vision during a dental or surgical procedure. The light typically consists of a magnifying lens, a reflector, a light bulb, and a connection to its integral batteries or battery pack; it is not a fibreoptic light.

Sterilization Methods#

Method table
Method

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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840329836924Black & Black SurgicalB60039B600392026-03-05
00840329837457N/AB80050B800502026-03-05
00840329837464N/AB80051B800512026-03-04
00840329836795N/AB8XFIC-V-CC1218-LLB8XFIC-V-CC1218-LL2026-01-16
00840329837013N/AB8XIII-526L-AHB8XIII-526L-AH2026-01-16
00840329836375N/AB8XLVH-640L-AHB8XLVH-640L-AH2026-01-15
00840329836382N/AB8BX-DBAS-523 PWRB8BX-DBAS-523 PWR2026-01-15
00840329836399N/AB8BX-DBAS-530 PWRB8BX-DBAS-530 PWR2026-01-15
00840329836405N/AB8BX-DMER-523 PWRB8BX-DMER-523 PWR2026-01-15
00840329836412N/AB8XDBAS-530LB8XDBAS-530L2026-01-15
00840329836429N/AB8XSPA-1120-LLB8XSPA-1120-LL2026-01-15
00840329836443N/AB8XFAN-149-LLB8XFAN-149-LL2026-01-15
00840329836450N/AB8BX-BAS-432 PWR BARBB8BX-BAS-432 PWR BARB2026-01-15
00840329836467N/AB8XFIC-I-CC1810-LLB8XFIC-I-CC1810-LL2026-01-15
00840329836474N/AB8XSPA-CC1810-LLB8XSPA-CC1810-LL2026-01-15
00840329836481N/AB8XMLV-1215-LLB8XMLV-1215-LL2026-01-15
00840329836498N/AB8AX-MIII-432 MLRB8AX-MIII-432 MLR2026-01-15
00840329836504N/AB8XMER-215-SHB8XMER-215-SH2026-01-15
00840329836542N/AB8BX-BAS-540 ANG PWRB8BX-BAS-540 ANG PWR2026-01-15
00840329836559BLACK & BLACK SURGICAL, INC.B8BX-III-432 PWR RTB8BX-III-432 PWR RT2026-01-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00615375014158Spark™ TruColor™METREX RESEARCH, LLCEBA2026-02-09
00615375014165Spark™ TruColor™METREX RESEARCH, LLCEBA2026-02-09
00615375014172Spark™ TruColor™METREX RESEARCH, LLCEBA2026-02-09
00615375014189Spark™ TruColor™METREX RESEARCH, LLCEBA2026-02-09
00615375014196Spark™ TruColor™METREX RESEARCH, LLCEBA2026-02-09
00615375014202Spark™ TruColor™METREX RESEARCH, LLCEBA2026-02-09
00615375013892Endeavour™ MDMETREX RESEARCH, LLCEBA2026-02-08
00615375013908Endeavour™ MDMETREX RESEARCH, LLCEBA2026-02-08
00615375013915Endeavour™ MDMETREX RESEARCH, LLCEBA2026-02-08
00615375013922Endeavour™ MDMETREX RESEARCH, LLCEBA2026-02-08
00615375013939Endeavour™ MDMETREX RESEARCH, LLCEBA2026-02-08
00615375013946Endeavour™ MDMETREX RESEARCH, LLCEBA2026-02-08
00615375013953Endeavour™ MDMETREX RESEARCH, LLCEBA2026-02-08
00615375013960Endeavour™ MDMETREX RESEARCH, LLCEBA2026-02-08
00615375013977Endeavour™ MDMETREX RESEARCH, LLCEBA2026-02-08
00615375013984Endeavour™ MDMETREX RESEARCH, LLCEBA2026-02-08
00615375013991Endeavour™ MDMETREX RESEARCH, LLCEBA2026-02-08
00615375014004Endeavour™ MDMETREX RESEARCH, LLCEBA2026-02-08
00615375014011Spark™ TruColor™METREX RESEARCH, LLCEBA2026-02-08
00615375014028Spark™ TruColor™METREX RESEARCH, LLCEBA2026-02-08
00615375014035Spark™ TruColor™METREX RESEARCH, LLCEBA2026-02-08
00615375014042Spark™ TruColor™METREX RESEARCH, LLCEBA2026-02-08
00615375014059Spark™ TruColor™METREX RESEARCH, LLCEBA2026-02-08
00615375014066Spark™ TruColor™METREX RESEARCH, LLCEBA2026-02-08
00615375014073Spark™ TruColor™METREX RESEARCH, LLCEBA2026-02-08
00615375014080Spark™ TruColor™METREX RESEARCH, LLCEBA2026-02-08
00615375014097Spark™ TruColor™METREX RESEARCH, LLCEBA2026-02-08
00615375014103Spark™ TruColor™METREX RESEARCH, LLCEBA2026-02-08
00615375014110Spark™ TruColor™METREX RESEARCH, LLCEBA2026-02-08
00615375014127Spark™ TruColor™METREX RESEARCH, LLCEBA2026-02-08