FDA.reportPublic FDA data

N/A

Primary DI
00840329808907
Brand
N/A
Company
BLACK & BLACK SURGICAL, INC.
Model
B65097
Catalog number
B65097
Device description
SofTouch™ ENDOSCOPIC CORRUGATOR GRASPER; 6"(15CM), SHAFT STRAIGHT, MALLEABLE
Published
2022-09-21
Public version status
Update
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
00840329808907PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840329808907008403298089078403298089070840329808907

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, tweezers-like, reusableA hand-held, manual, open-surgery instrument designed to facilitate grasping and manipulation of soft-tissues. It has a tweezers-like design (may be a micro/fine instrument) with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles). It is made of high-grade stainless steel, available in various sizes, and may have carbide inserts at the working end. It is not an electrosurgical device and not dedicated to ophthalmic surgery. This is a reusable device intended to be sterilized prior to use.

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
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
00840329808914N/AB65099B650992022-09-21
00840329807306N/AB62124B621242022-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD6520450Surgical DirectSurgical Direct, Inc.GEN2026-10-06
B382SD6562120Surgical DirectSurgical Direct, Inc.GEN2026-10-06
00190776433048MillenniumAvalign Technologies, Inc.GEN2026-10-01
00190776433130MillenniumAvalign Technologies, Inc.GEN2026-10-01
00190776433147MillenniumAvalign Technologies, Inc.GEN2026-10-01
00190776433178MillenniumAvalign Technologies, Inc.GEN2026-10-01
B382SD8160490Surgical DirectSurgical Direct, Inc.GEN2026-09-30
00190776432829MillenniumAvalign Technologies, Inc.GEN2026-09-29
00190776432898MillenniumAvalign Technologies, Inc.GEN2026-09-29
B382SD4937851340Surgical DirectSurgical Direct, Inc.GEN2026-09-29
00190776432522MillenniumAvalign Technologies, Inc.GEN2026-09-28
00190776432553MillenniumAvalign Technologies, Inc.GEN2026-09-28
00190776432560MillenniumAvalign Technologies, Inc.GEN2026-09-28
00190776432577MillenniumAvalign Technologies, Inc.GEN2026-09-28
00190776432744MillenniumAvalign Technologies, Inc.GEN2026-09-28
00724995268985Snowden-PencerSTERIS Deutschland GmbHGEN2026-09-25
00724995268992Snowden-PencerSTERIS Deutschland GmbHGEN2026-09-25
00724995269005Snowden-PencerSTERIS Deutschland GmbHGEN2026-09-25
00724995269012Snowden-PencerSTERIS Deutschland GmbHGEN2026-09-25
00724995269029Snowden-PencerSTERIS Deutschland GmbHGEN2026-09-25
00724995269036Snowden-PencerSTERIS Deutschland GmbHGEN2026-09-25
00724995269043Snowden-PencerSTERIS Deutschland GmbHGEN2026-09-25
B35665124160American MedicalsAmerican MedicalsGEN2026-09-25
00724995266752Snowden-PencerSTERIS Deutschland GmbHGEN2026-09-24
00190776431273MillenniumAvalign Technologies, Inc.GEN2026-09-22
00190776432096MillenniumAvalign Technologies, Inc.GEN2026-09-22
04058749037364NAFehling Instruments GmbH & Co. KGGEN2026-09-21
00190776431006MillenniumAvalign Technologies, Inc.GEN2026-09-18
00190776431013MillenniumAvalign Technologies, Inc.GEN2026-09-18
00190776429034MillenniumAvalign Technologies, Inc.GEN2026-09-04