FDA.report

N/A

Primary DI
00840329800147
Brand
N/A
Company
BLACK & BLACK SURGICAL, INC.
Model
B78533
Catalog number
B78533
Device description
VOROTEK SLIM LINE O SCOPE HEADBAND EXPANDED KIT CASE - AUD - WITHOUT OTOSCOPE FOR 78503
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

Related Records

Contact Domains

Product Codes

CodeName
EBALIGHT, SURGICAL HEADLIGHT

Product Code Classifications

CodeDeviceSpecialtyClass
EBALight, Surgical HeadlightDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840329800147PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840329800147008403298001478403298001470840329800147

GMDN Terms

TermDefinition
Ear speculum, reusableA rigid plastic or metal tube that is cone-shaped (i.e., it tapers down from a standard instrument fitting size to a small opening) and is either hand-held and manually inserted, or fitted onto a compatible otoscope, and then inserted into the ear canal to create a channel for examination, suction, irrigation, or the insertion of another surgical device during an ear/nose/throat (ENT) procedure. It may in addition be intended for use with an audiometer and might also be referred to as an ear cannula or probe. This is a reusable device.

Sterilization Methods

Method

Contacts

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
false

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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

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