FDA.reportPublic FDA data

N/A

Primary DI
00840329805623
Brand
N/A
Company
BLACK & BLACK SURGICAL, INC.
Model
B61065
Catalog number
B61065
Device description
"NAHAI RAKE RETRACTOR; 7''(18CM), 2 PRONG 3/4""(19MM) WIDE"
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
GADRETRACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840329805623PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840329805623008403298056238403298056230840329805623

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, reusableA hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. 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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00840329808914N/AB65099B650992022-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776433543MillenniumAvalign Technologies, Inc.GAD2026-10-06
00841536148497ThompsonThompson Surgical Instruments, Inc.GAD2026-10-06
B7687419600Buxton Biomedical, IncBUXTON BIOMEDICAL, INC.GAD2026-10-06
00190776433086MillenniumAvalign Technologies, Inc.GAD2026-10-01
00190776433116MillenniumAvalign Technologies, Inc.GAD2026-10-01
00190776433154MillenniumAvalign Technologies, Inc.GAD2026-10-01
00190776433161MillenniumAvalign Technologies, Inc.GAD2026-10-01
00190776432959MillenniumAvalign Technologies, Inc.GAD2026-09-30
00190776432997MillenniumAvalign Technologies, Inc.GAD2026-09-30
G1415180500Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
G141518555120Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
G141528202010Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
G141572105820Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
G141572106810Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
G141572108210Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
G14157211460Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
G14157212010Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
G14157213040Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
00190776432874MillenniumAvalign Technologies, Inc.GAD2026-09-29
00190776432515MillenniumAvalign Technologies, Inc.GAD2026-09-28
00190776432591MillenniumAvalign Technologies, Inc.GAD2026-09-28
00190776432621MillenniumAvalign Technologies, Inc.GAD2026-09-28
00190776432638MillenniumAvalign Technologies, Inc.GAD2026-09-28
00190776432669MillenniumAvalign Technologies, Inc.GAD2026-09-28
00840329838829N/ABLACK & BLACK SURGICAL, INC.GAD2026-09-28
00840329838980N/ABLACK & BLACK SURGICAL, INC.GAD2026-09-28
00840329839000N/ABLACK & BLACK SURGICAL, INC.GAD2026-09-28
00840329839017N/ABLACK & BLACK SURGICAL, INC.GAD2026-09-28
00190776432287MillenniumAvalign Technologies, Inc.GAD2026-09-24
00190776432294MillenniumAvalign Technologies, Inc.GAD2026-09-24