N/A B78571

GUDID B089B785710

VOROTEK "V SCOPE" - HEADBAND; 2 DIOPTER, 10HR BATTERY PACK, CHARGER AND CASE

BLACK & BLACK SURGICAL, INC.

Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp
Primary Device IDB089B785710
NIH Device Record Key0412058c-9ce6-4fa8-a748-f9157754efef
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model NumberB78571
Catalog NumberB78571
Company DUNS004382282
Company NameBLACK & BLACK SURGICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(770)414-4880
Emailinfo@blackandblacksurgical.com
Phone+1(770)414-4880
Emailinfo@blackandblacksurgical.com
Phone+1(770)414-4880
Emailinfo@blackandblacksurgical.com
Phone+1(770)414-4880
Emailinfo@blackandblacksurgical.com
Phone+1(770)414-4880
Emailinfo@blackandblacksurgical.com
Phone+1(770)414-4880
Emailinfo@blackandblacksurgical.com
Phone+1(770)414-4880
Emailinfo@blackandblacksurgical.com
Phone+1(770)414-4880
Emailinfo@blackandblacksurgical.com
Phone+1(770)414-4880
Emailinfo@blackandblacksurgical.com
Phone+1(770)414-4880
Emailinfo@blackandblacksurgical.com
Phone+1(770)414-4880
Emailinfo@blackandblacksurgical.com
Phone+1(770)414-4880
Emailinfo@blackandblacksurgical.com
Phone+1(770)414-4880
Emailinfo@blackandblacksurgical.com
Phone+1(770)414-4880
Emailinfo@blackandblacksurgical.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB089B785710 [Primary]

FDA Product Code

EBALIGHT, SURGICAL HEADLIGHT

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-20
Device Publish Date2022-09-12

On-Brand Devices [N/A]

B089B8XV833LL0TOLEDO "V" UNDERMINER; 8GA X 33CM, LUER LOCK
B089B8XV426L0TOLEDO "V" UNDERMINER; 4MM X 26CM LARGE HANDLE
B089B8XV425L0TOLEDO "V" UNDERMINER; 4MM X 25CM LARGE HANDLE
B089B8XV420L0TOLEDO "V" UNDERMINER; 4MM X 20CM LARGE HANDLE
B089B8XTT421L0TIGER TIP CANNULA; 4MM X 21CM LARGE HANDLE
B089B8XTT326L0TIGER TIP CANNULA; 3MM X 26CM LARGE HANDLE
B089B8XTT321L0TIGER TIP CANNULA; 3MM X 21CM LARGE HANDLE
B089B8XTP215L0TRIPORT 3 CANNULA; 2MM X 15CM LARGE HANDLE
B089B8XTIDH1136LL0DOUBLE HELIX TUMESCENT INFILTRATION CANNULA; LUER LOCK 11GAX36CM
B089B8XTIDH1126LL0DOUBLE HELIX TUMESCENT INFILTRATION CANNULA; LUER LOCK 11GAX26CM
B089B8XTICC1812LL0TUMESCENT INFILTRATION CANNULA; LUER LOCK, CONCAVE CURVE 18GAX12CM
B089B8XTI832LLTPR0TUMESCENT INFILTRATION CANNULA; LUER LOCK 8GA X 32CM, TAPERED
B089B8XTI832LL0TUMESCENT INFILTRATION CANNULA; LUER LOCK 8GA X 32CM
B089B8XTI827LLTPR0TUMESCENT INFILTRATION CANNULA; LUER LOCK, 8GA X 27CM, TAPERED
B089B8XTI61615LL0TUMESC INFILTR CANNULA; OULE HELIX PATTERN - HOLES NO FURTHER THAN 1CM FM TIP; LUER LOCK 16GAX15
B089B8XTI325SYR0TUMESCENT INFILTRATION CANNULA 60CC SYRINGE HUB 3MMX25CM
B089B8XTI189LL0TUMESCENT INFILTRATION CANNULA; LUER LOCK 18GAX9CM
B089B8XTI188LL0TUMESCENT INFILTRATION CANNULA; LUER LOCK 18GAX8CM
B089B8XTI1815LL0TUMESCENT INFILTRATION CANNULA; LUER LOCK 18GAX15CM
B089B8XTI169LL0TUMESCENT INFILTRATION CANNULA; LUER LOCK 16GAX9CM
B089B8XTI168LL0TUMESCENT INFILTRATION CANNULA; LUER LOCK 16GAX8CM
B089B8XTI167LL0TUMESCENT INFILTRATION CANNULA; LUER LOCK 16GAX7CM
B089B8XTI1630LL0TUMESCENT INFILTRATION CANNULA; LUER LOCK 16GAX30CM
B089B8XTI1617LL0TUMESCENT INFILTRATION CANNULA; LUER LOCK 16GAX17CM
B089B8XTI1612LL0TUMESCENT INFILTRATION CANNULA; LUER LOCK 16GAX12CM
B089B8XTI146LL0TUMESCENT INFILTRATION CANNULA; LUER LOCK 14GAX6CM
B089B8XTI1450LL0TUMESCENT INFILTRATION CANNULA; LUER LOCK 14GAX50CM
B089B8XTI1435LL0TUMESCENT INFILTRATION CANNULA; LUER LOCK 14GAX35CM
B089B8XTI1430LL0TUMESCENT INFILTRATION CANNULA; LUER LOCK 14GAX30CM
B089B8XTI1426LL12HOLES0TUMESCENT INFILTRATION CANNULA; LUER LOCK 14GAX26CM W/ 12 HOLES
B089B8XTI1423LL0TUMESCENT INFILTRATION CANNULA; LUER LOCK 14GAX23CM
B089B8XTI1415LL12HOLES0TUMESCENT INFILTRATION CANNULA; LUER LOCK 14GAX15CM W/ 12 HOLES
B089B8XTI1410LL0TUMESCENT INFILTRATION CANNULA; LUER LOCK 14GAX10CM
B089B8XTI1325LL0TUMESCENT INFILTRATION CANNULA; LUER LOCK, 13GAX25CM
B089B8XTI1250LL0TUMESCENT INFILTRATION CANNULA; LUER LOCK 12GAX50CM
B089B8XTI1240LL0TUMESCENT INFILTRATION CANNULA; LUER LOCK 12GAX40CM
B089B8XTI1235LL0TUMESCENT INFILTRATION CANNULA; LUER LOCK 12GAX35CM
B089B8XTI1230LL0TUMESCENT INFILTRATION CANNULA; LUER LOCK 12GAX30CM
B089B8XTI1226LLCVD0TUMESCENT INFILTRATION CANNULA; LUER LOCK 12GAX26CM #2 TAPER
B089B8XTI1226LLANG200TUMESCENT INFILTRATION CANNULA; LUER LOCK 12GAX26CM ANGLED 20 DEGREES
B089B8XTI1225LL0TUMESCENT INFILTRATION CANNULA; LUER LOCK, 12GAX25CM
B089B8XTI1223LL0TUMESCENT INFILTRATION CANNULA; LUER LOCK 12GAX23CM
B089B8XTI1222LL0TUMESCENT INFILTRATION CANNULA; LUER LOCK 12GAX22CM
B089B8XTI1220LLANG200TUMESCENT INFILTRATION CANNULA; LUER LOCK 12GAX20CM ANGLED 20 DEGREES
B089B8XTI1218LL0TUMESCENT INFILTRATION CANNULA; LUER LOCK 12GAX18CM
B089B8XTI1135LL0TUMESCENT INFILTRATION CANNULA; LUER LOCK 11GAX35CM
B089B8XTI1130LL0TUMESCENT INFILTRATION CANNULA; LUER LOCK 11GAX30CM
B089B8XTI1124LL0TUMESCENT INFILTRATION CANNULA; LUER LOCK 11GAX24CM
B089B8XTI1112LL0TUMESCENT INFILTRATION CANNULA; LUER LOCK 11GAX12CM
B089B8XTI1111LL0TUMESCENT INFILTRATION CANNULA; LUER LOCK 11GAX11CM
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