FDA.reportPublic FDA data

BLACK & BLACK SURGICAL, INC.

Primary DI
00840329838751
Brand
BLACK & BLACK SURGICAL, INC.
Company
BLACK & BLACK SURGICAL, INC.
Model
B95261
Catalog number
B95261
Device description
COTTLE TENACULUM SINGLE PRONG
Published
2026-10-30
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
GENFORCEPS, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GENForceps, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840329838751PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840329838751008403298387518403298387510840329838751

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
00840329838744BLACK & BLACK SURGICAL, INC.B92134B921342026-10-30
00840329838805N/AB89172B891722026-10-30
00840329838836BLACK & BLACK SURGICAL, INC.B64042B640422026-10-30
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850090726003Intrace USAPILOTIS TECH LLCGEN2026-10-31
00850090726010Intrace USAPILOTIS TECH LLCGEN2026-10-31
00850090726027Intrace USAPILOTIS TECH LLCGEN2026-10-31
G383S1085WM7786614SURJEXSURJEXGEN2026-10-31
G383S1085WM77866155SURJEXSURJEXGEN2026-10-31
G383S1092WM0202S3SURJEXSURJEXGEN2026-10-31
G383S1092WM0205S3SURJEXSURJEXGEN2026-10-31
G383S1092WM0220S3SURJEXSURJEXGEN2026-10-31
G383S1092WM0405S3SURJEXSURJEXGEN2026-10-31
G383S1092WM0413S3SURJEXSURJEXGEN2026-10-31
G383S1092WM0418S3M4SURJEXSURJEXGEN2026-10-31
G383S1092WM0914S3N7SURJEXSURJEXGEN2026-10-31
G383S1092WM0948S3SURJEXSURJEXGEN2026-10-31
G383S1092WM0958S3SURJEXSURJEXGEN2026-10-31
G383S1092WM1025615SURJEXSURJEXGEN2026-10-31
G383S1092WWM0313S3SURJEXSURJEXGEN2026-10-31
G383S1092WWM0315S3SURJEXSURJEXGEN2026-10-31
G383S109317410S4SURJEXSURJEXGEN2026-10-31
G383S1093WM3197476SURJEXSURJEXGEN2026-10-31
G383S1094WM0958S3R5SURJEXSURJEXGEN2026-10-31
G383S1094WM77866055SURJEXSURJEXGEN2026-10-31
G383S1098WM1325320SURJEXSURJEXGEN2026-10-31
G383S1098WM1325324SURJEXSURJEXGEN2026-10-31
G383S1098WM1325325SURJEXSURJEXGEN2026-10-31
G383S1098WM1325326SURJEXSURJEXGEN2026-10-31
G383S1098WM1325327SURJEXSURJEXGEN2026-10-31
00190776437305MillenniumAvalign Technologies, Inc.GEN2026-10-30
B382SD920556110Surgical DirectSurgical Direct, Inc.GEN2026-10-30
00190776437176MillenniumAvalign Technologies, Inc.GEN2026-10-28
00190776437183MillenniumAvalign Technologies, Inc.GEN2026-10-28