FDA.report

N/A

Primary DI
B089B662610
Brand
N/A
Company
BLACK & BLACK SURGICAL, INC.
Model
B66261
Catalog number
B66261
Device description
FLASH TRAY STAINLESS STEEL; 6-1/2" X 10" X 2'', W/O LID, W/ DRAINAGE PERFORATIONS ON BOTTOM
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

Related Records

Contact Domains

Product Codes

CodeName
FSMTRAY, SURGICAL, INSTRUMENT

Product Code Classifications

CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B089B662610PrimaryHIBCC0

GMDN Terms

TermDefinition
Sterilization/disinfection container, reusableA receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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 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 DIBrandCompanyProduct codePublished
07898663491562HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663493108HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663493467HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663495263HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663495270HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663495751HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663496239HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663497267HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663498080HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663498097HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663499292HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663499926HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663499957HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663499971HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089802307HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089803113HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089803441HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089804349HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089804950HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089806367HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089806626HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089807012HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089807029HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089807999HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089808583HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089808682HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089808729HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089809511HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089809528HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089809535HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24