FDA.reportPublic FDA data

N/A

Primary DI
B089B89SCH0
Brand
N/A
Company
BLACK & BLACK SURGICAL, INC.
Model
B89SCH
Catalog number
B89SCH
Device description
SYRINGE CUP HOLDER
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
FSMTRAY, SURGICAL, INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B089B89SCH0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Medicine cup, reusableA cup specially designed for administering medicine to patients or disabled persons. It will typically be made of stainless steel or durable plastic materials and will typically have graduated markings to facilitate providing specific doses of medication. It may be used both for tablets and fluids. 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
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840329838669N/AB60360B603602026-10-15
00840329838676BLACK & BLACK SURGICAL, INC.B64037B640372026-09-30
00840329838683BLACK & BLACK SURGICAL, INC.B64040B640402026-09-30
00840329838768BLACK & BLACK SURGICAL, INC.B8BX-TI-1420 PWRB8BX-TI-1420 PWR2026-09-30
00840329838775BLACK & BLACK SURGICAL, INC.B8BX-TI-1632 PWRB8BX-TI-1632 PWR2026-09-30
00840329838928BLACK & BLACK SURGICAL, INC.B8BX-TPIII-3.526 PWRB8BX-TPIII-3.526 PWR2026-09-30
00840329838935BLACK & BLACK SURGICAL, INC.B8BX-TPIII-3.526 PWR CC-TPRB8BX-TPIII-3.526 PWR CC-TPR2026-09-30
00840329838942BLACK & BLACK SURGICAL, INC.B8BX-MER-3.526 PWRB8BX-MER-3.526 PWR2026-09-30
00840329838867N/AB61266B612662026-09-29
00840329838829N/AB99013B990132026-09-28
00840329838959BLACK & BLACK SURGICAL, INC.B8XKCII-3.530L-AHB8XKCII-3.530L-AH2026-09-28
00840329838966BLACK & BLACK SURGICAL, INC.B8BX-EVL-332 ANG PWR-WALLB8BX-EVL-332 ANG PWR-WALL2026-09-28
00840329838973BLACK & BLACK SURGICAL, INC.B8BX-EVL-432 ANG PWR-WALLB8BX-EVL-432 ANG PWR-WALL2026-09-28
00840329838980N/AB99012B990122026-09-28
00840329839000N/AB61013B610132026-09-28
00840329839017N/AB61012B610122026-09-28
00840329838454BLACK & BLACK SURGICAL, INC.B8X-DMER-440-EH ANGB8X-DMER-440-EH ANG2026-07-30
00840329808884N/AB65092B650922022-09-21
00840329808891N/AB65096B650962022-09-21
00840329808907N/AB65097B650972022-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00190376766140Valence Robotic Navigation SystemALPHATEC SPINE, INC.FSM2026-10-29
00190376776941Valence Robotic Navigation SystemALPHATEC SPINE, INC.FSM2026-10-29
00190376778358Valence Robotic Navigation SystemALPHATEC SPINE, INC.FSM2026-10-29
04250337122104iLESSYS® Delta Access TrayJoimax GmbHFSM2026-10-28
04250337122111iLESSYS® Delta Resection TrayJoimax GmbHFSM2026-10-28
06954454000564COTISENHuanghua Promisee Dental Co., Ltd.FSM2026-10-28
06954454000571COTISENHuanghua Promisee Dental Co., Ltd.FSM2026-10-28
06954454000588COTISENHuanghua Promisee Dental Co., Ltd.FSM2026-10-28
06954454000595COTISENHuanghua Promisee Dental Co., Ltd.FSM2026-10-28
06954454000601COTISENHuanghua Promisee Dental Co., Ltd.FSM2026-10-28
06954454001202COTISENHuanghua Promisee Dental Co., Ltd.FSM2026-10-28
06954454001271COTISENHuanghua Promisee Dental Co., Ltd.FSM2026-10-28
M739223000700Nav Instruments General TrayCAPTIVA SPINE, INC.FSM2026-10-28
M739223000800Nav Instruments Pedicle Screws TrayCAPTIVA SPINE, INC.FSM2026-10-28
M739253001012Discectomy Prep TrayCAPTIVA SPINE, INC.FSM2026-10-28
00889024702660OsseoFitZimmer, Inc.FSM2026-10-27
00889024702677OsseoFitZimmer, Inc.FSM2026-10-27
00889024702684OsseoFitZimmer, Inc.FSM2026-10-27
00889024702691OsseoFitZimmer, Inc.FSM2026-10-27
00889024702707OsseoFitZimmer, Inc.FSM2026-10-27
00889024702714OsseoFitZimmer, Inc.FSM2026-10-27
04056481148232Sterilization Tray Accessories ENT/CMFBrainlab SEFSM2026-10-27
04056481148249Sterilization Tray Accessories Cranial (2 of 2)Brainlab SEFSM2026-10-27
04250337118497Vaporgrip® Bipo Sterilization TrayJoimax GmbHFSM2026-10-27
04250337119265TESSYS® Sterilization Tray for InstrumentsJoimax GmbHFSM2026-10-27
04250337119272TESSYS® Sterilization Tray for InstrumentsJoimax GmbHFSM2026-10-27
00889024699854IDENTITY HumeralZimmer, Inc.FSM2026-10-21
00889024699861IDENTITY HumeralZimmer, Inc.FSM2026-10-21
00889024699878IDENTITY HumeralZimmer, Inc.FSM2026-10-21