FDA.reportPublic FDA data

N/A

Primary DI
00840329808914
Brand
N/A
Company
BLACK & BLACK SURGICAL, INC.
Model
B65099
Catalog number
B65099
Device description
SofTouch™ ENDOSCOPIC NEEDLE HOLDER; 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
FHQHOLDER, NEEDLE, GASTROENTEROLOGIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHQHolder, Needle, GastroenterologicGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840329808914PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840329808914008403298089148403298089140840329808914

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle holder, reusableA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. 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
00840329808884N/AB65092B650922022-09-21
00840329808891N/AB65096B650962022-09-21
00840329808907N/AB65097B650972022-09-21
00840329807306N/AB62124B621242022-09-21
00840329830397ASPIRATION TUBINGB89205B892052026-07-30
00840329834494BLACK & BLACK SURGICAL, INC.B89113B891132026-07-30
00840329836856BLACK & BLACK SURGICAL, INC.B89217B892172026-07-30
00840329837648ASPIRATION TUBINGB89206B892062026-07-30
00840329838409BLACK & BLACK SURGICAL, INC.B8XBAS-332L-ANGB8XBAS-332L-ANG2026-07-30
00840329838416BLACK & BLACK SURGICAL, INC.B8XCC-332L-AHB8XCC-332L-AH2026-07-30
00840329838430BLACK & BLACK SURGICAL, INC.B8BX-DMER-632 PWRB8BX-DMER-632 PWR2026-07-30
00840329838454BLACK & BLACK SURGICAL, INC.B8X-DMER-440-EH ANGB8X-DMER-440-EH ANG2026-07-30
00840329838515BLACK & BLACK SURGICAL, INC.B8XSTD-515-SYRB8XSTD-515-SYR2026-07-30
00840329800277N/AB89107B891072022-09-21
00840329800291N/AB89109B891092022-09-21
00840329838225BLACK & BLACK SURGICAL, INC.B8XBAS-432BH-AH-RTB8XBAS-432BH-AH-RT2026-06-08
00840329838232BLACK & BLACK SURGICAL, INC.B8XIII-332BH-AH-RTB8XIII-332BH-AH-RT2026-06-08
00840329838249BLACK & BLACK SURGICAL, INC.B8XIII-432BH-AH-RTB8XIII-432BH-AH-RT2026-06-08
00840329805982N/AB61115B611152022-09-21
00840329806033N/AB61126B611262022-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776419684MillenniumAvalign Technologies, Inc.FHQ2026-08-25
00850083997007Suture SheildSUTURE SHIELD, INC.FHQ2026-08-03
B382SD45267180Surgical DirectSurgical Direct, Inc.FHQ2026-08-03
B382SD90557818E0Surgical DirectSurgical Direct, Inc.FHQ2026-07-29
00810143905076SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143905083SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143905106SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143907193SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143908671SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143908701SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143909081SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143909753SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143909760SURGIPROSSurgipros, LLCFHQ2026-07-28
00810212931517SURGIPROSSurgipros, LLCFHQ2026-07-28
00810212931678SURGIPROSSurgipros, LLCFHQ2026-07-28
00810212934709SURGIPROSSurgipros, LLCFHQ2026-07-28
00810212934716SURGIPROSSurgipros, LLCFHQ2026-07-28
00810212934723SURGIPROSSurgipros, LLCFHQ2026-07-28
00810212934921SURGIPROSSurgipros, LLCFHQ2026-07-28
00810212934938SURGIPROSSurgipros, LLCFHQ2026-07-28
00810212934945SURGIPROSSurgipros, LLCFHQ2026-07-28
B382SD9056791110Surgical DirectSurgical Direct, Inc.FHQ2026-07-28
B382SD905701100Surgical DirectSurgical Direct, Inc.FHQ2026-07-23
00840183531980BR Surgical, LLCBR Surgical, LLCFHQ2026-07-22
00190776403751MillenniumAvalign Technologies, Inc.FHQ2026-07-21
00840183531720BR Surgical, LLCBR Surgical, LLCFHQ2026-07-21
00840183532475BR Surgical, LLCBR Surgical, LLCFHQ2026-07-21
00840183532499BR Surgical, LLCBR Surgical, LLCFHQ2026-07-21
00190776397104MillenniumAvalign Technologies, Inc.FHQ2026-07-16
04059453084217Hermann Medizintechnik GmbHHermann Medizintechnik GmbHFHQ2026-07-16