FDA.reportPublic FDA data

N/A

Primary DI
00840329811365
Brand
N/A
Company
BLACK & BLACK SURGICAL, INC.
Model
B78540
Catalog number
B78540
Device description
"VOROTEK ""M SCOPE"", SPEC FRAME"
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
EBALIGHT, SURGICAL HEADLIGHT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBALight, Surgical HeadlightDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840329811365PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840329811365008403298113658403298113650840329811365

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
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840329811518N/AB79808B798082022-09-21
00840329811525N/AB79809B798092022-09-21
B089B784600Headlight CableB78460B784602016-07-29
B089B784640Headlight CableB78464B784642016-07-29
B089B797180Fiberoptic Cable B79718B797182016-07-29
B089B797190Fiberoptic Cable B79719B797192016-07-29
B089B797220Fiberoptic Cable B79722B797222016-07-29
B089B797230Fiberoptic Cable B79723B797232016-07-29
B089B797240Fiberoptic Cable B79724B797242016-07-29
B089B797250Fiberoptic Cable B79725B797252016-07-29
B089B797260Fiberoptic Cable B79726B797262016-07-29
B089B797270Fiberoptic Cable B79727B797272016-07-29
B089B797280Fiberoptic Cable B79728B797282016-07-29
B089B797590Fiberoptic Cable B79759B797592016-07-29
B089B797600Fiberoptic Cable B79760B797602016-07-29
B089B797610Fiberoptic Cable B79761B797612016-07-29
B089B797650Fiberoptic Cable B79765B797652016-07-29
B089B797660Fiberoptic Cable B79766B797662016-07-29
B089B797670Fiberoptic Cable B79767B797672016-07-29
B089B797680Fiberoptic Cable B79768B797682016-07-29

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